Heart valve prosthesis delivery

ABSTRACT

The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/240,259, filed Jan. 4, 2019, which claims the benefit of andpriority to U.S. Provisional Application No. 62/614,489, filed on Jan.7, 2018, U.S. Provisional Application No. 62/756,556, filed on Nov. 6,2018, and U.S. Provisional Application No. 62/781,537, filed on Dec. 18,2018, the entireties of each of which are incorporated herein byreference.

TECHNICAL FIELD

The present disclosure relates to devices and methods for thepercutaneous delivery and implantation of a cardiac valve prosthesis.The valve prosthesis can be delivered in a compressed state within asheath to the defective native valve and released in situ.

BACKGROUND

Prosthetic heart valves are used to replace damaged or diseased heartvalves. In vertebrate animals, the heart is a muscular organ with fourpumping chambers: the left and right atria and the left and rightventricles, each provided with its own one-way valve. The natural heartvalves are identified as the aortic, mitral (or bicuspid), tricuspid andpulmonary valves. Prosthetic heart valves can be used to replace any ofthese naturally occurring valves, although repair or replacement of theaortic or mitral valves is more common since they reside in the leftside of the heart where pressures are the greatest.

A conventional heart valve replacement surgery involves accessing theheart in the patient's thoracic cavity through a longitudinal incisionin the chest. For example, a median sternotomy requires cutting throughthe sternum and forcing the two opposing halves of the rib cage to bespread apart, allowing access to the thoracic cavity and heart within.The patient is then placed on cardiopulmonary bypass which involvesstopping the heart to permit access to the internal chambers. Suchopen-heart surgery is particularly invasive and involves a lengthy anddifficult recovery period.

The foregoing examples of the related art and limitations relatedtherewith are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the drawings.

SUMMARY

The present disclosure relates to heart valve prostheses, deliverydevices, and actuation handles that can facilitate delivery of a heartvalve prosthesis to a defective native valve structure in a patient,such as the aortic valve. In some embodiments, the delivery can beperformed using a transcatheter approach.

The delivery devices and actuation handles can enable a clinician tomore easily maneuver and advance the delivery device through bloodvessels leading to the heart, as well as through tortuosities of suchvessels, using a transvascular approach, such as a transfemoralapproach. Indeed, some embodiments disclosed herein enable components ofthe heart valve prosthesis to be advanced in tandem, as an axiallydisplaced unit (with or without partial or full overlapping between thecomponents), while still being movably connected, movably attached,flexibly connected, displaceably connected, linked, or coupled to eachother, thereby minimizing a passing profile or cross section of thedelivery device. Optionally, the distance from which the components ofthe heart valve prosthesis may be serially displaced may be variable,such that various components are adjacent or potentially inches or feetaway. Further, the interconnection of components of the heart valveprosthesis can allow different degrees of motion and can be set into anengaged or retained position that provides a limited range of motion. Insome embodiments, the engaged position can also provide a presetrelative positioning of the components of the heart valve prosthesis tofacilitate proper placement and release of the heart valve prosthesis.Additionally, some embodiments can provide a clinician with a highdegree of control and enhance the maneuverability of the heart valveprosthesis when implanting the heart valve prosthesis at the targetlocation.

In accordance with some embodiments, a procedure is provided for atranscatheter aortic valve implantation (TAVI) and/or a transcatheteraortic valve replacement (TAVR). For example, in the TAVI procedure, aclinician can anchor the anchoring component of the heart valveprosthesis relative to the aortic valve annulus to guide the placementof the prosthetic leaflet structure. The valve prosthesis can compriseprosthetic leaflets, an anchoring component, a valve frame component,and a tethering component, which allows the anchoring component and theframe component to be placed serially in a delivery device in order toreduce the overall crossing profile of the delivery device. Thetethering component can be coupled to the anchoring component and theframe component to permit a range of motion and in some embodiments, torestrict other motion. The tethering component can be slidable relativeto the anchoring component between a released position and a retainedposition. In the retained position, the tethering component can allowrelative movement of the valve frame component and a preset orpredetermined position which the valve frame component is optimallylocated relative to the anchoring component, which can facilitateplacement and release of the valve prosthesis.

For example, in some embodiments, the interconnection can be implementedusing a novel approach of looping the tethering component around“U-shaped” members of the anchoring component. The tethering componentcan slide along the anchoring component until reaching the end of thetravel on the anchoring component. The clinician can exert tension onthe tethering component until the tethering component is seated in theengagement area. This action can ratchet the tethering component andengage it to the engagement area of the anchoring component. Thereafter,the tethering component establishes a fixed range of longitudinal travelof the valve frame component relative to the anchoring component, andsubsequently a proper position of the valve frame component in theanatomy, based only on the clinician placing the anchoring componentinto the aortic sinus region (the clinician can see under fluoroscopyand can “feel” the placement).

Thus, some embodiments disclosed herein advantageously provide adelivery device that has a reduced passing profile or cross section,thereby enabling delivery of a heart valve prosthesis in a safer, lessinvasive manner than traditional approaches. As such, open-heart surgerycan be avoided because the heart valve prosthesis can be advanced to theheart using a catheter via an access point in the blood vessel, such asthe femoral artery. This provides enormous benefits to patients,including less trauma to the patient, greater ease of recovery, andpotentially fewer surgical risks, to name a few.

Further, although the in-series arrangement of the anchoring componentand the valve frame component overcomes the challenge of creating alow-profile delivery device, the advantageous arrangement of theinterconnection overcomes yet another critical challenge: how tooptimally position the valve prosthesis within the native valvestructure and to reliably anchor it in place. Indeed, some embodimentsdisclosed herein address this challenge and teach structures and methodsfor using a tethering component to operatively couple the anchoringcomponent to the valve frame component in a delivery device.

The delivery device can comprise a proximal sheath that can house atleast a portion of the anchoring component and a distal carrier assemblythat can house at least a portion of the valve frame component. Thetethering component can extend between the anchoring component and thevalve frame component when the valve prosthesis is loaded onto thedelivery device. The valve prosthesis can be released from the deliverydevice in a component-by-component manner that allows the clinician tomaneuver and position the anchoring component first, followed by thevalve frame component.

In some embodiments, the anchoring component can be coupled to anengagement member or grasper of the delivery device that allows theclinician to push or pull the anchoring component. The grasper can bereleased from engagement with the anchoring component when the anchoringcomponent is properly seated relative to the native valve annulus.

In addition, in some embodiments, the distal carrier assembly of thedelivery device can comprise two components or be referred to as atwo-part nose cone assembly. In accordance with some embodiments is therealization that if a single tubular member or nose cone is used tosheath most of the valve frame component, various problems can arise dueto the expansive force and corresponding compressive force required tomaintain the valve frame component in its compressed configurationduring delivery to a target valve structure. Because the delivery devicecan be quite long (for example, in some embodiments, up to about 4 to 6feet or more, although the length can be less than 4, 3, or 2 feet),these forces can create a much stiffer distal section of the deliverydevice. Further, these forces can require a high degree of longitudinalforce to release the valve frame component due to the high frictionalforces due to the radial force of the valve implant.

Thus, the radial and frictional forces of such configurations can causeproblems of matching handle actuation and make precise positioning ofthe distal end of the delivery device quite difficult. For example, thefriction tends to be a variable friction that makes it difficult for aclinician to position the components of the valve prosthesis relative toeach other, which can lead to unpredictable and/or imprecise componentpositioning or deployment. Thus, some embodiments herein include therealization that by separating the distal carrier or nose cone assemblyinto two components (such as a proximal and distal enclosure), thecomponents can cover less surface area of the valve frame component,thus reducing the radial forces exerted on a single component and theresultant friction that would need to be overcome in order to actuate orrelease the valve frame component. As such, the problems associated witha single tubular member are much more manageable.

Additionally, in some embodiments, a two-part distal carrier assemblycan also enable the clinician to release the valve frame component in anadvantageous sequence. For example, during testing and development ofthe valve prostheses, deployment systems, and handle actuators disclosedherein, some embodiments demonstrate advantageous characteristics bypermitting a distal end portion of the valve frame component to openfirst, before a proximal end portion of the valve frame component isreleased. In some embodiments, the valve frame component can have one ormore anchors at its distal end portion that can supplement the outwardexpansive force (due to self-expansion of the valve frame component) andits resultant frictional engagement. By opening the distal end portionfirst (by actuation of distal nose cone or enclosure), the distal endportion can “flower” out and engage with the native valve structure tosecure a longitudinal position of the valve frame component relative tothe native valve structure. Thereafter, the self-expanding radialoutward force of the valve frame component can cause the proximal endportion of the valve frame component to become disengaged and releasedfrom the proximal nose cone or enclosure.

Some embodiments can also provide self-aligning features to allow thecomponents of the delivery assembly to be moved from a releasing state(where the components of the valve prosthesis are released fromengagement with the delivery assembly) to a nested or stowed state inwhich outer surfaces of portions of the delivery assembly are aligned orin an abutting position at a seam. This alignment, abutment, orpositioning can provide a smoother outer profile that can reduce thelikelihood of having the delivery assembly snag or become entangled withthe prosthetic valve after being released or with other vasculature asthe delivery assembly is retrieved from the patient's vasculature.

For example, in some embodiments, the distal carrier or nose coneassembly can include an internal plunger or piston mechanism. Theplunger mechanism can be compressed when the valve frame component isloaded into the delivery device. As the valve frame component isreleased, a spring of the plunger mechanism can push a plunger head to apredetermined position relative to the distal carrier assembly. Inaccordance with some embodiments, in the predetermined position, theplunger head can be exposed partially from the distal enclosure and beconfigured to engage with the proximal enclosure to align the proximaland distal enclosures relative to each other in an abuttingrelationship. The plunger head can therefore engage with both theproximal and distal enclosures to reduce the likelihood of catching orsnagging of the delivery device with the prosthetic valve or othervasculature during retrieval of the delivery device. Additionally, suchfeatures can also aid in proximal retraction of the delivery device intoan introducer sheath. Moreover, the plunger head can also provide aproximal surface that can be in contact with the distal end portion ofthe valve frame component and not catch or snag with the intricate meshof the valve frame component, thereby ensuring that the valve framecomponent can flower open without catching on the delivery device.Accordingly, some embodiments can include one or more of theseadvantageous features that address the problem of having the valveprosthesis and/or the delivery device catch or snag on each other orsurrounding anatomy.

Furthermore, due to the reduced cross-sectional profile of the deliverydevice, retrograde delivery of a valve prosthesis through the bloodvessel (such as femoral artery in a transfemoral retrograde approach)can be possible with reduced risk of trauma to the surroundingvasculature. For example, retrograde delivery of the valve prosthesisthrough the femoral artery has been associated with aortofemoral arteryinjury and/or rupture, and carries a potential risk of stroke as thedelivery involves crossing the aortic arch. However, the variousfeatures and advantages achieved using some embodiments disclosed hereinprovide a valve prosthesis and delivery device that minimizes damagealong the delivery path of device while also minimizing the invasivenature of the implantation procedure.

Additional embodiments of the present devices and methods, and the like,will be apparent from the following description, drawings, examples, andclaims. As can be appreciated from the foregoing and followingdescription, each and every feature described herein, and each and everycombination of two or more of such features, is included within thescope of the present disclosure provided that the features included insuch a combination are not mutually inconsistent. In addition, anyfeature or combination of features may be specifically excluded oromitted from any embodiment of the present disclosure. Additionalaspects and advantages of the present disclosure are set forth in thefollowing description and claims, particularly when considered inconjunction with the accompanying examples and drawings.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

Certain features of valve prostheses, delivery devices, actuationhandles, other devices, systems, and methods which can be implementedwith the valve prostheses, delivery devices, actuation handles, otherdevices, systems, and methods discussed in the present disclosure, canimplement features of and/or be used in combination with other featuresof valve prostheses, delivery devices, actuation handles, other devices,systems, and methods described for example in International ApplicationNo. PCT/US2019/012406, entitled HEART VALVE PROSTHESIS AND DELIVERY,filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, Cheng Yong Yang,Jinhua Zhu, and Dennis Michael McMahon, and in International ApplicationNo. PCT/US2019/012408, entitled PROSTHETIC HEART VALVE DELIVERY SYSTEM,filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, and Cheng YongYang, the entirety of each of which is incorporated herein by reference.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of illustrative embodiments of the inventions aredescribed below with reference to the drawings. The illustratedembodiments are intended to illustrate, but not to limit, theinventions. The drawings contain the following figures:

FIG. 1 illustrates delivery of a valve prosthesis using a valve deliverydevice in a transfemoral retrograde approach, according to someembodiments.

FIG. 2 shows a valve prosthesis, according to some embodiments.

FIG. 3 is a side cross-sectional view of the valve prosthesis of FIG. 2loaded onto a valve delivery device, according to some embodiments.

FIG. 4 is a perspective view the valve delivery device of FIG. 3 showinga grasper mechanism for engaging a valve anchor, according to someembodiments.

FIGS. 5A and 5B are side cross-sectional views illustrating operation ofa distal carrier assembly of the valve delivery device of FIG. 3 with anose cone protector, according to some embodiments.

FIG. 6 shows an embodiments of a link mechanism for the valve prosthesisof FIG. 2, in which the valve prosthesis is loaded onto a valve deliverydevice, according to some embodiments.

FIGS. 7A-7D are side and end cross-sectional views illustrating aspectsand operation of a distal carrier assembly and a proximal enclosure of adelivery device, according to some embodiments.

FIG. 7E is a cross-sectional view taken along section lines 7E-7E ofFIG. 7D illustrating a structure of a proximal enclosure of the distalcarrier assembly of the delivery device of FIG. 6, according to someembodiments.

FIG. 8A is a perspective view of a nose cone protector, according tosome embodiments.

FIGS. 8B-8F are side cross-sectional views illustrating operation of adistal carrier assembly of the delivery device with the nose coneprotector of FIG. 8A, according to some embodiments.

FIGS. 9A and 9B are views of a valve delivery device having a graspermechanism with a grasper alignment hub, according to some embodiments.

FIG. 9C is a view of the grasper alignment hub assembly of FIG. 9B,according to some embodiments.

FIGS. 10A and 10B are perspective views illustrating a structure of aproximal enclosure of the delivery device of FIG. 6, according to someembodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

Further, while the present disclosure sets forth specific details ofvarious embodiments, it will be appreciated that the description isillustrative only and should not be construed in any way as limiting.Additionally, it is contemplated that although particular embodiments ofthe present disclosure may be disclosed or shown in the context ofaortic valve prostheses, such embodiments may be used in other cardiacvalve prosthesis applications. Furthermore, various applications of suchembodiments and modifications thereto, which may occur to those who areskilled in the art, are also encompassed by the general conceptsdescribed herein.

Various embodiments will now be described more fully hereinafter. Suchembodiments may, however, be embodied in many different forms and shouldnot be construed as limited to the embodiments set forth herein; rather,these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey its scope to those skilled in theart. Thus, one or more features shown or otherwise disclosed in anembodiment herein may be interchangeably used or incorporated intoanother embodiment that may not expressly show or disclose suchfeature(s). Further, one or more features shown or otherwise disclosedfor an embodiment herein may be excluded from such embodiment, unlessexpressly indicated, using skill in the art.

As with all cardiac valves, a healthy aortic valve will open to allowblood flow and close to prevent backflow of blood. However, disease anddysfunction of the valve can result in regurgitation or decreased bloodflow (stenosis). In such cases, a replacement aortic valve prosthesismust be used to perform the functions of a healthy aortic valve.

Minimally invasive surgical techniques are evolving, where a valveprosthesis can be introduced into a patient using a catheter that isintroduced via a small incision that provides access to, for example, afemoral artery or directly to the heart. These implantation techniqueshave shown promising results in providing treatment options for patientswho are poor open surgical candidates. Nevertheless, challenges stillremain in such catheter-based delivery of prosthetic valves.

For example, in according with an aspect of at least one embodimentdisclosed herein is the realization that advancing a conventionaltubular delivery device through a vessel exerts stress against thevessel walls and carries the risk of damaging the vessel walls. Further,in according with an aspect of at least one embodiment disclosed hereinis the realization that transcatheter prosthetic valves may not be ableto treat patients with aortic regurgitation. Additionally, in accordingwith an aspect of at least one embodiment disclosed herein is therealization that conventional prosthetic valves may be difficult toposition, may require rapid ventricular pacing, and may have limitedexpansion. Accordingly, implantation and use of conventional prostheticvalves may result in complications, such as vascular damage, moderate tosevere paravalvular leakage, valve thrombosis/migration, coronary arteryblockage, and excessive stress due to excessive radial force.

The present disclosure describes various aspects of heart valveprostheses that can be delivered to a defective heart valve in apatient. The valve prostheses can comprise at least one valve anchor orclasper, which is movably connected, movably attached, flexiblyconnected, displaceably connected, linked, or coupled to aradially-expandable valve support or frame. The valve frame can compriseprosthetic valve leaflets or cusps and provide the functionality of thenative heart valve. Certain features of valve prostheses, which can beimplemented with the prostheses discussed in the present disclosure, arealso further described for example, in U.S. Pat. No. 8,366,768, theentirety of which is incorporated herein by reference.

Thus, the present disclosure provides a variety of features that can beoptionally incorporated or excluded from any of the embodimentsexplicitly discussed or illustrated herein. These modifications andcombinations of features can be performed by a person of skill toachieve advantages and benefits discussed herein. Further, certainmodifications or combinations are indicated or suggested herein, but itis contemplated that a person skill can implement or exclude certainaspects or features disclosed herein in developing a suitable embodimentor implementation of these teachings. Advantageously, variousembodiments described herein allow for treating patients with aorticregurgitation, permit precise axial, angular, and radial positioning ofthe valve prosthesis, minimize valve migration and paravalvular leakagewhile avoiding damage to the valve annulus, minimize the need for apacemaker, and decrease the likelihood of blocking the coronary artery.

Some of these features and benefits of the heart valve prosthesis areillustrated with respect to FIGS. 1-5. FIG. 1 illustrates the use of thedelivery device 200 in a human heart 300. The heart 300 can comprise anaorta 301 having an aortic arch 302 and an aortic valve 304. The aortavalve 304 can comprise a plurality of native valve leaflets 306 andseparate the aorta 301 from the left ventricle 310. In accordance withsome embodiments, the delivery device 200 can be advanced retrogradethrough the aorta 301 until reaching and being positioned through thenative valve leaflets 306 of the aortic valve 304.

With reference to FIGS. 1 and 2, during delivery of the valve prosthesis100 to the native valve site, the valve anchor 104 and the support frame102 can be positioned in tandem, as an axially displaced unit (with orwithout partial or full overlapping between the anchor and the frame)along the longitudinal axis of the delivery device 200. Thisconfiguration, as opposed to a concentric arrangement, can allow a moreradially compact configuration of the components of the valve prosthesis100, creating a much smaller cross-section and facilitating acatheter-based delivery. This can improve the flexibility of thedelivery device 200, enabling the delivery device 200 to be advancedover a guidewire through the tortuous geometries of the circulatorysystem, and in particular, the aortic arch 302. Indeed, even withguidewire-directed delivery devices, the aortic arch 302 represents adifficult obstacle due to its sudden and high-degree of curvature.Often, this is a limiting constraint for some surgeries or deliverydevices. However, in accordance with the various benefits and advantagesof some embodiments disclosed herein, as illustrated in FIG. 1, thedelivery device 200 can be advanced over the aortic arch 302 to a targetlocation in the region of the aortic valve 304.

As shown in FIG. 1, once the valve anchor 104 is in the desiredposition, the support frame 102 can be released from the distal carrierassembly and expanded into apposition with the native valve leaflets 306and the internal aspects of the valve anchor 104, thus sandwiching thenative valve leaflets 306 between the support frame 102 and the valveanchor 104. Advantageously, by sandwiching the native valve leaflets 306between the support frame and the valve anchor, the valve prosthesis 100can have reduced reliance on radial force retention. Further, bysandwiching the native valve leaflets 306 between the support frame andthe valve anchor, the likelihood of the native valve leaflets 306blocking the opening of the coronary artery is reduced, which may bebeneficial for patients with low coronary ostia distance, and inpatients with an existing valve prosthesis, who may need a new valveprosthesis inside the existing valve prosthesis (valve-in-valveapplication). The support frame and the valve anchor can thus expandinto contact with the aortic valve 304, exerting a chronic outward forceagainst the native valve leaflets 306 and aortic valve annulus 320.Thereafter, the prosthetic valve leaflets of the prosthesis 100 canbegin to function in the manner desired and provide the same operationas a native valve.

According to some embodiments, the present disclosure also provides ahandle actuator that can be used to control the operation of thepresently disclosed delivery device and allow a clinician to reliablyand accurately control the delivery of the valve prosthesis. FIG. 1illustrates features and operation of the handle actuator, according tosome embodiments, for delivering a valve prosthesis using a handleactuator 500.

FIG. 1 illustrates the handle actuator 500, which can control one ormore functions of a delivery device (e.g., the delivery device 200discussed herein) for delivering of a valve prosthesis (e.g., the heartvalve prosthesis 100 discussed herein). The handle actuator 500 cancomprise a plurality of actuators or movable elements, such as knobs orbuttons. The movable elements can permit a clinician to control one ormore operations of the delivery device 200. The handle actuator 500 cancomprise a control handle 510 having a longitudinal axis 512. The handleactuator 500 may be also referred to as a control unit. In someembodiments, the handle actuator 500 may be coupled to the second coremember 222 (shown, e.g., in FIGS. 3 and 5). The control handle 510 cansupport the actuators and be held by the clinician during the procedure.

In some embodiments, as illustrated in FIG. 1, the handle actuator 500can comprise a first movable element 520, a second movable element 522,a third movable element 524, and a fourth movable element 526. The firstmovable element 520 can be used to steer the delivery device 200, thesecond movable element 522 can be used to release the valve anchor, thethird movable element 524 can be used to release nosecone or valveframe, and the fourth movable element 526 can be used as a nose conetoggle lock. The first movable element 520, the second movable element522, the third movable element 524, and the fourth movable element 526may be also referred to as the first control element 520, the secondcontrol element 522, the third control element 524, and the fourthcontrol element 526.

Optionally, in some embodiments, one or more of the movable elements,such as the second movable element 522 and/or the third movable element524, can include a button or slider safety switch 529 that prevent theunintentional rotation of the moveable elements. The safety switch 529can be configured as resilient button or slider mechanisms that can beactuated to release a lock that provides resistance to rotational ortranslational movement of the respective movable element. In someembodiments, the movable elements can have a raised feature thatprovides a visual indication of rotation and facilitates tactileengagement and actuation by the clinician. Other features of the handleactuator 500 and methods for operating the handle actuator 500 arediscussed and illustrated in FIGS. 13A-13H of U.S. Patent ApplicationNo. 62/781,537, filed on Dec. 18, 2018, the entirety of which isincorporated herein by reference.

Referring now to FIG. 2, a valve prosthesis 100 and components thereofare shown in various configurations. The valve prosthesis 100 can bedelivered to a patient using a suitable delivery device, includingembodiments of the delivery devices disclosed herein. The valveprosthesis 100 can comprise a support frame 102 and an anchoringcomponent or valve anchor 104 to which the support frame 102 is movablyconnected, movably attached, flexibly connected, displaceably connected,linked, or coupled.

The valve prosthesis 100 can be configured such that components of thevalve prosthesis 100 to be advanced in series while still being movablyconnected, movably attached, flexibly connected, displaceably connected,linked, or coupled to each other, thereby minimizing a passing profileor cross section of the delivery system. The interconnection ofcomponents of the valve prosthesis 100 can allow different degrees ofmotion and can be set into an engaged or retained position that providesa limited range of motion. In some embodiments, the engaged position canalso provide a preset relative positioning of the components of thevalve prosthesis 100 to facilitate proper placement and release of thevalve prosthesis 100. Additionally, some embodiments can provide aclinician with a high degree of control and enhance the maneuverabilityof the valve prosthesis 100 when implanting the valve prosthesis 100 atthe target location.

In some embodiments, the valve anchor 104 can be coupled to the supportframe 102 when the support frame 102 is in the compact configurationprior to delivery and expansion. In some embodiments, the valve anchor104 is not fixed to the support frame 102. Further, the valve anchor 104can be separate from the support frame 102 or formed separately from andlater coupled to the support frame 102. Thus, although a least a portionof the valve anchor 104, e.g., the anchoring leg, may be in contact withor otherwise reversibly attached or connected to the support frame 102,no part of the valve anchor 104 is fixed, e.g., welded or otherwiseirreversibly adhered, to the support frame 102. Alternatively stated,the valve anchor 104, which may be in contact with or otherwisereversibly attached to the support frame 102, is not irreversibly fixedto the support frame 102.

Further, upon reaching the target location, the valve anchor 104 can bemovably coupled to the support frame 102 in a manner that prevents theentire valve anchor 104 from being radially displaced from the supportframe 102 when the valve anchor 104 is initially expanded. For example,portions of the valve anchor 104 can be radially displaced from thesupport frame during initial “landing” of the valve anchor 104 againstthe native valve structure at the target location. In some embodiments,the support frame 102 can be deployed or expanded within the nativeheart valve structure, and the valve anchor 104 can become sandwichedbetween the support frame and the native valve tissue, becoming at leastpartially, and possibly fully, immobilized. The valve anchor 104 canfunction to hold the expanded support frame 102 in place within thenative valve structure.

Optionally, the support frame 102 may be referred to as a valve frame orvalve support frame. FIG. 2 illustrates the support frame 102 alignedwith and expanded within the valve anchor 104, in a configuration thatis achieved when the prosthesis 100 is released and expanded within thenative valve structure. The native valve structure includes the valveannulus or leaflets. This expanded configuration, serves to secure thevalve prosthesis 100 within the native valve annulus by engaging thenative valve structure. In some embodiments, the expanded configurationof the valve prosthesis 100 may reduce reliance on securing the valveprosthesis 100 with radial force exerted by the support frame 102 andthe valve anchor 104 via the sandwiching or compression of the nativevalve leaflets between the support frame 102 and the valve anchor 104 ofthe valve prosthesis 100. Further, as discussed further herein, duringimplantation of the valve prosthesis 100, the support frame 102 and thevalve anchor 104 can be movable relative to each other in expandedand/or compressed states in order to facilitate proper positioning ofthe prosthesis 100 relative to the native valve annulus and surroundingstructures. Indeed, various advantages made possible by the prosthesis100 and delivery device disclosed herein allow a clinician to achieve ahigher degree of precision in placing the prosthesis 100, as well asmaking such increased precision easier to achieve.

Referring to FIG. 2, the support frame 102 can comprise an outer orexternal surface and defines a central orifice about a longitudinal axis120. The longitudinal axis 120 corresponds to an inflow-outflow axis ofthe prosthesis 100. In some embodiments, the valve prosthesis 100further comprises a plurality of prosthetic valve leaflets or cusps 106that are coupled to the support frame 102. The support frame 102 canprovide a structural support for the valve leaflets 106. The valveleaflets 106 can have surfaces defining a reversibly sealable openingfor unidirectional flow of a liquid through the prosthesis 100. Theprosthesis 100 can include three valve leaflets 106 for a tri-leafletconfiguration. As appreciated, mono-leaflet, bi-leaflet, and/ormulti-leaflet configurations are also possible. For example, the valveleaflets can be coupled to the support frame 102 to span and controlfluid flow through the lumen of the prosthesis 100. The prostheticleaflets 106 can comprise one or more synthetic materials, engineeredbiological tissues, biological valvular leaflet tissues, pericardialtissues, cross-linked pericardial tissues, aortic root tissue,chemically or biologically processed/treated tissue, or combinationsthereof. In some embodiments, the pericardial tissue is selected frombut not limited to the group consisting of bovine, equine, porcine,ovine, human tissue, or combinations thereof.

Furthermore, in some embodiments, the valve prosthesis 100 can comprisea sealing component or membrane 108 that can be attached to an insidesurface, an outside surface, and/or enclose the support frame 102, suchas by being laminated onto inner and outer surfaces of the support frame102. Thus, the valve leaflets 106 can be coupled to the support frame102 and/or the membrane 108. In some embodiments, the membrane 108 canrestrict blood flow in areas around the valve leaflets 106 so that bloodflow occurs only between the valve leaflets 106 through the lumen of theprosthesis 100, as in a healthy native heart valve.

The support frame 102 and/or the valve anchor 104 can comprise a braidedframe, a wire frame, or a laser-cut frame (e.g., laser-cut tubularmesh), as shown in FIG. 2. In some embodiments, the support frame 102and/or the valve anchor 104 can comprise a shape-memory metal, which canchange shape at a designated temperature or temperature range or byinducing stress. Alternatively, the self-expanding frames can includethose having a spring-bias. The material from which either the supportframe 102 and/or the valve anchor 104 is fabricated can allow thesupport frame 102 and/or the valve anchor 104 to automatically expand toits functional size and shape when deployed but also allows the supportframe 102 and/or the valve anchor 104 to be radially compressed to asmaller profile for delivery through the patient's vasculature. Examplesof suitable materials for self-expanding components described herein(e.g., support frames, valve anchors, locking members) include, but arenot limited to, medical grade nickel titanium alloys, tantalum, platinumalloys, niobium alloys, cobalt alloys, alginate, or combinationsthereof. Shape memory alloys having superelastic properties generallymade from ratios of nickel and titanium, commonly known as Nitinol, arepreferred materials. In some embodiments, self-expanding componentsdescribed herein can include materials including, but not limited toshape memory plastics, polymers, and thermoplastic materials which areinert in the body. In an alternative embodiment, either the supportframe 102 and/or the valve anchor 104 is not self-expanding, and may beexpanded, for example, using a balloon catheter as is well known in theart. Examples of suitable materials for components described hereininclude, but are not limited to, stainless steel and titanium.Optionally, either the support frame 102 and/or the valve anchor 104 cancomprise radiopaque materials to allow visualization under fluoroscopyor other imaging techniques.

Optionally, the support frame 102 can comprise one or more hooks 109that can engage with tissue of the native valve annulus, the aorticroot, or any other portion of the native valve when the support frame102 is expanded within the native valve annulus. The hooks 109 can beengaged with the native valve annulus to secure the prosthesis 100 andmitigate any downstream or antegrade migration of the prosthesis 100during operation.

The support frame 102 can comprise a first end portion 110 and a secondend portion 112. The first end portion 110 can be positioned upstream ofthe second end portion 112 when the prosthesis 100 is released withinthe native valve annulus. As illustrated in FIG. 2, the first endportion 110 of the support frame 102 can be shaped as a generally flatend of a cylinder, where first apices 114 of the support frame 102 liegenerally in a common plane, which can be oriented substantiallyperpendicular relative to a longitudinal axis 120 of the prosthesis 100.Further, the second end portion 112 can be shaped to include a series ofpeaks 130 and valleys 132, where second apices or minor peaks 136 of thesupport frame 102 collectively form contours of the peaks 130 andvalleys 132. The peaks 130 and valleys 132 of the second end portion 112can be positioned downstream of the first end portion 110 when theprosthesis is seated within the native valve annulus.

In accordance with some embodiments, the prosthetic leaflets 106 can becoupled relative to the support frame 102 at locations circumferentiallyaligned with the peaks 130 of the second end portion 112, as shown inFIG. 2. In some embodiments, the prosthetic leaflets 106 can be coupledto the membrane 108 using ultra-high molecular weight polyethylenesutures. This unique configuration can advantageously enable theprosthesis 100 to more fully approximate the native valve structures,permit a more natural blood flow without limiting or otherwiseconstraining movement of the valve leaflets 106, and more seamlesslyintegrate with surrounding architecture of the heart. In someembodiments, the prosthetic leaflets 106 can comprise features,including, but not limited to, planar features, flat features,three-dimensional features, Bézier curves, or other suitable shapes.Optionally, the prosthetic leaflets 106 can be shaped through fixationon a leaflet-shaped mandrel.

The valve anchor 104 can comprise at least one U-shaped member, valveclasper, sinus locator, valve positioner, or valve hanger 140 thatextends about a longitudinal axis of the valve anchor 104. Asillustrated in FIG. 2, the valve anchor 104 can comprise a plurality oflobes or U-shaped members 140, such as three U-shaped members 140, butcan have fewer or more. In some embodiments, U-shaped members 140 can beconfigured to engage with or fit inside the posterior aortic sinus, theleft aortic sinus, and the right aortic sinus of a native aortic valve.The U-shaped members 140 can each have a peak portion 142 and a baseportion 144. The U-shaped members 140 can each comprise first and secondlegs 146, 148. The first and second legs 146, 148 of the adjacentU-shaped members 140 can be interconnected at the peak portions 142thereof. Further, the U-shaped members 140 can comprise shapes otherthan a U-shape, such as a wave-shape, V-shape, W-shape, or zig-zag.Optionally, multiple valve anchors 104 can each comprise one or moreU-shaped members 140, wherein the multiple valve anchors 104cooperatively engage with the aortic sinus to anchor the valveprosthesis as described herein.

The valve prosthesis 100 can include a link mechanism that interconnectsthe support frame 102 to the valve anchor 104. The link mechanism cancomprise a single, continuous strand of material or multiple,independent strands of material that interconnects the support frame 102to the valve anchor 104. Further, the link mechanism can attach in asliding, engaged, or fixed manner to one or more locations on thesupport frame 102 and/or on the valve anchor 104.

In accordance with some embodiments, the valve anchor 104 may optionallydefine one or more engagement areas in one or more portions of the valveanchor 104, where a link mechanism may engage with the one or moreengagement areas to restrict relative motion between the support frame102 and the valve anchor 104.

For example, at the interconnection of the respective peak portions, thevalve anchor 104 can define an engagement area 150. The engagement area150 may also be referred to as a peak portion engagement area.

As illustrated in FIG. 2, the support frame 102 can be flexibly coupledto the valve anchor 104 via one or more tethering components or linkmechanisms 160. The link mechanism 160 can be coupled to the supportframe 102 and to the valve anchor 104, permitting relative movementbetween the support frame 102 and the valve anchor 104. However, thelink mechanism 160 can be configured to limit relative movement betweenthe support frame 102 and to the valve anchor 104. In some embodiments,the engagement area 150 of the valve anchor 104 can be used to furtherrestrict relative motion of the support frame 102 with respect to thevalve anchor 104 when the link mechanism 160 is engaged in theengagement area 150, as discussed herein.

The valve anchor 104 can thus be coupled to the support frame 102 topermit the valve anchor 104 to be moved axially or longitudinallyrelative to the support frame 102 while still remaining coupled to thesupport frame 102. This advantageous feature of some embodiments canallow a clinician to independently position the valve anchor 104relative to the support frame 102. For example, in a transcatheteraortic valve replacement, the clinician can independently position thevalve anchor 104 in order to fit the base portions 144 of the valveanchor 104 into the aortic sinus. Portions of the of aortic sinus mayinclude the posterior aortic sinus, the left aortic sinus, and/or theright aortic sinus, of a native aortic valve. In some embodiments, thevalve anchor 104 can rotate to be aligned in the respective aorticsinuses. In some embodiments, the interconnection of the valve anchor104 to the support frame 102 can allow the valve anchor 104 toself-rotate to be aligned in the aortic sinus. Thereafter, with thevalve anchor 104 “landed” in the respective aortic sinuses, theinterconnection of the valve anchor 104 to the support frame 102 furtherenables the support frame 102 to translated along the longitudinal axis120 of the valve prosthesis 100. In some embodiments, during thedelivery procedure, the valve anchor 104 can be moved at least axiallyfrom a proximal position relative to the support frame 102, to a distalposition relative to the support frame 102, or from either of suchpositions to a position in which the support frame 102 at leastpartially longitudinally overlaps with or is concentric within the valveanchor 104. A range of various positions are illustrated, for example,in FIGS. 11A-11F of U.S. Patent Application No. 62/781,537, filed onDec. 18, 2018, the entirety of which is incorporated herein byreference.

For example, when the support frame 102 is nested within the valveanchor 104, as shown in FIG. 2, the base portions 144 of the valveanchor 104 can be longitudinally spaced apart from first end portion 110of the support frame 102 along the longitudinal axis 120 at a distancewhich is about 10% to about 100%, about 25% to about 75%, about 33% toabout 100%, about 33% to about 66%, about 25% to about 75%, about 50% toabout 75%, or about 60% to about 70% of a length of the support frame102. In some embodiments, the support frame 102 can be contained orotherwise fully overlapping the valve anchor 104. In some embodiments,the support frame 102 can have minimal or no overlap with the valveanchor 104. The support frame 102 can move along the longitudinal axis120 to overlap the valve anchor 104 by about 10% to about 100%, about25% to about 75%, about 33% to about 100%, about 33% to about 66%, about25% to about 75%, or about 50% to about 75% of the length of the supportframe 102. In accordance with some embodiments, the U-shaped members 140of the valve anchor 104 can be in nested positions within the aorticsinuses, and the base portions 144 of the valve anchor 104 can be aboutlongitudinally adjacent to, coplanar with, or spaced apart from thefirst end portion 110 of the support frame 102. For example, the valveanchor 104 can be in a nested position when at least one base portion144 of the valve anchor 104 is in contact with or adjacent to the basalattachments of the native aortic valvar leaflets. Further, the first endportion 110 of the support frame 102 can be longitudinally adjacent to,coplanar with, or spaced apart from the native valve structure (or avirtual ring formed by the basal attachments of the native aortic valvarleaflets) or with the ventriculo-aortic junction.

The link mechanism 160 can allow rotational and longitudinal movement ofthe valve anchor 104 relative to the support frame 102. Thus, despitethe presence of the link mechanism 160, the valve anchor 104 can moverotationally with respect to the support frame 102. Further, in someembodiments, the link mechanism 160 can be fixedly attached or coupledto the support frame 102 and fixedly or slidably attached to the valveanchor 104. When the support frame 102 is moved relative to the valveanchor 104, the link mechanism 160 can slide along the U-shaped members140. In some embodiments, the U-shaped members 140 have a generallyarcuate or convex shape (as illustrated with the U-shaped members ofFIG. 2) that allows unrestricted movement of the link mechanism 160along the geometry of the first and second legs 146, 148 of the U-shapedmembers 140. When the link mechanism 160 is allowed to slide along thefirst and second legs 146, 148 of the U-shaped members 140, the valveprosthesis 100 can be in a position referred to as a “slidable” state.In the slidable state, the range of longitudinal and/or rotationalmovement of the support frame 102 relative to the valve anchor 104 isvariable and may be its greatest because the link mechanism 160 can movealong the first and second legs 146, 148 of the U-shaped members 140.

In some embodiments, the link mechanism 160 can be fixedly attached orcoupled to the support frame 102 and fixedly attached to the valveanchor 104. When the support frame 102 is moved relative to the valveanchor 104, the link mechanism 160 can stretch, flex, deform elasticallyand/or plastically. As the link mechanism 160 deforms, the range oflongitudinal and/or rotational movement of the support frame 102relative to the valve anchor 104 is variable as allowed by thedeformation of the link mechanism 160.

In some embodiments, the link mechanism 160 can have multiple linkmembers, where each link member is coupled to and intermittently spacedabout a circumference of the support frame 102. Each link member may beslidably coupled to a respective one of the U-shaped members 140.Further, the link mechanism 160 can have multiple link members that arecoupled together in an end-to-end manner. Moreover, the link mechanism160 can have multiple link members that are individually coupled at oneand to the support frame 102 and at another and to the valve anchor 104.Each of the link members can be slidable along the valve anchor 104, asdisclosed similarly herein and not described again herein for brevity.

As noted above, however, the valve anchor 104 can also compriseengagement areas 150 that can engage with the link mechanism 160 inorder to restrict relative motion between the support frame 102 and thevalve anchor 104. The engagement areas 150 can include one or more localconcavities or other geometric shapes that can engage or trap the linkmechanism 160 once the link mechanism 160 passes into the engagementarea 150. Various embodiments of engagement areas 150 can be used topermit the slidable link mechanism 160 to enter into the engagement area150, but restrict the link mechanism 160 from exiting the engagementarea 150, such as those disclosed in FIGS. 2A-2G of U.S. PatentApplication No. 62/781,537, filed on Dec. 18, 2018, noted above.

Referring now to FIG. 3, a side cross-sectional view is provided of thevalve prosthesis 100 loaded onto the delivery device 200, according tosome embodiments. Among the many features illustrated in FIG. 3, FIG. 3shows that a proximal enclosure 210 of delivery device 200 can extendover both the valve anchor 104 and the support frame 102. Thus, inaccordance with some embodiments, in the compressed or deliveryconfiguration shown in FIG. 3, the link mechanism (not shown) can extendbetween the valve anchor 104 and the support frame 102 and be at leastpartially enclosed within the proximal enclosure 210 (depending on theattachment point of the link mechanism with the support frame 102 andthe longitudinal extent of the proximal enclosure 210).

In addition, FIG. 3 illustrates that the valve anchor 104 can comprise alink motion limiter 240. The link motion limiter 240 can provide anenlarged profile of the wireframe structure of the valve anchor 104 soas to restrict or prevent motion of the link mechanism as the linkmechanism slides along the U-shaped member of the valve anchor 104.

In alternative embodiments of the delivery device 200, the valve anchor104 and the support frame 102 can both be enclosed within the proximalsheath component 204 prior to and during delivery prior to releasing thevalve anchor 104. For example, in some embodiments, the valve anchor 104can be distal to the support frame 102 wherein the valve anchor 104 isnear the distal end of the proximal sheath component 204 and the supportframe 102 can be approximately adjacent to the valve anchor 104 (in aserial configuration) and is proximal to the valve anchor 104. In someembodiments of the delivery device 200, the valve anchor 104 and thesupport frame 102 can both be enclosed within the proximal sheathcomponent 204, with the support frame 102 near the distal end of theproximal sheath component 204 and the valve anchor 104 beingapproximately adjacent to the support frame 102 and proximal to thesupport frame 102.

Further, in alternative embodiments of the delivery device 200, thevalve anchor 104 can be enclosed within the distal carrier assembly 206and the support frame 102 can be enclosed within the proximal sheathcomponent 204 prior to and during delivery of the valve prosthesis. Forexample, in some embodiments of the delivery device 200, both the valveanchor 104 and the support frame 102 can be enclosed within the distalcarrier assembly 206 and the support frame 102 can be enclosed withinthe proximal sheath component 204 prior to and during delivery of thevalve prosthesis. In this configuration, the valve anchor 104 and thesupport frame 102 can be approximately adjacent to one another (in aserial configuration) and the valve anchor 104 can be positionedproximal to the support frame 102. Other details of delivery devices andprostheses are provided in U.S. Patent Application No. 62/781,537, notedabove and incorporated herein by reference.

In addition, FIG. 3 illustrates that an anchor retention component 170can be used to engage the engagement areas 150 of the valve anchor 104with the control member or a grasper 224 to facilitate movement andcontrol of the positioning of the valve anchor 104 during delivery. Asdiscussed with regard to FIGS. 7G-7I of U.S. Patent Application No.62/781,537, noted above, this engagement can maintain the engagementareas 150 in a common plane 152, oriented generally perpendicularrelative to the longitudinal axis of the delivery device 200.

FIG. 4 illustrates aspects of the delivery device 200 a, according to atleast one embodiment. These figures do not illustrate all of thecomponents of the delivery device that can be incorporated into anembodiment. However, the features illustrated in these figures can beincorporated into embodiments of the delivery device to facilitateengagement with the valve anchor and/or facilitate delivery and controlof the valve anchor during implantation and release of the valve anchorat the target location.

For example, FIG. 4 illustrates an embodiment of a delivery device 200 athat comprises a grasper mechanism. The grasper mechanism can be used tosecurely couple a portion of the valve anchor with the delivery deviceto permit the clinician to control movement, operation, and deploymentof the valve anchor. The grasper mechanism can engage one or moreportions or structures of the valve anchor using a variety of couplingmechanisms, which can use attachment means including mechanicalengagement, dissolvable structures, chemically reactive degradablestructures, electrolytically degradable structures, and the like.

In some embodiments, the grasper mechanism can be a tubular graspermechanism. The delivery device 200 a, shown in FIG. 4, can comprise agrasper 224 a that can engage with and control the longitudinal positionof the valve anchor 104 a. The grasper 224 a of the delivery device 200a can comprise an engagement wire that is movable within a lumen of atubular enclosure. The valve anchor 104 a can be configured to comprisea clasper tang extending from an engagement area 150 d or 150 d′ of thevalve anchor 104 a. The engagement wire can comprise a distal endportion that includes pins, ridges, or protrusions that can be coupledto the engagement structure of the clasper tang at the engagement areaof the valve anchor 104 a. When engaged together, the engagement wireand the clasper tang can be proximally drawn into the lumen of thetubular enclosure, which secures the engagement wire and the claspertang relative to each other in both radial and longitudinal directions.However, when the engagement wire and the clasper tang are moved outsideof the lumen of the tubular enclosure, the engagement wire and theclasper tang can be disengaged as the valve anchor 104 a and the claspertang expand radially, thereby disengaging the clasper tang from theengagement wire. These and other features are discussed in U.S. PatentApplication No. 62/781,537, noted above and incorporated herein byreference.

During use, after the valve anchor has been released from within theproximal sheath and after the valve anchor and the valve frame have beenreleased from the delivery device, the delivery device can be configuredto be compactly reassembled and withdrawn into the introducer sheath inorder to minimize any damage to the blood vessel through which thedelivery device was advanced.

For example, in at least one embodiment, as illustrated in FIG. 5A, theproximal enclosure 210 can comprise a proximal section 250 to facilitaterealignment (e.g., radial realignment) of the distal end portion 208 ofthe proximal sheath component 204 with the proximal enclosure 210.

As illustrated in FIG. 5A, the proximal section 250 can be coupled tothe core member 220. Further, the proximal section 250 can optionally beconical or tapered in a proximal direction and/or have circumferentialnodes 252 and/or circumferential cavities 254 that can facilitaterealignment of the proximal sheath component 204 relative to theproximal enclosure 210 along a longitudinal axis of the delivery device200. The tapering of the proximal section 250 can allow the distal endportion 208 of the proximal sheath component 204 to smoothly advancedistally over the proximal section 250, and the circumferential nodes252 can contact an inner surface of the distal end portion 208 of theproximal sheath component 204 as the distal end portion 208 approachesthe proximal abutment surface 214.

For example, as illustrated in FIG. 5A, the circumferential nodes 252may gradually taper from the proximal abutment surface 214 in theproximal direction. With such a configuration, as the proximal sheathcomponent 204 slides distally toward the proximal enclosure 210, thecircumferential nodes 252 can advantageously guide the distal endportion 208 of the proximal sheath component 204 distally toward theproximal abutment surface 214 of the proximal enclosure 210 so that theouter surface of the proximal sheath component 204 is aligned with anouter surface of the proximal enclosure 210. Thus, the outer surfaces ofthe proximal enclosure 210 and the proximal sheath component 204 canprovide a smooth outer profile for the delivery device 200 that canadvantageously reduce the likelihood that the delivery device 200catches or otherwise damages tissue within a body lumen as the deliverydevice 200 is moved therewithin.

Optionally, the proximal section 250 can comprise three circumferentialnodes 252 and three circumferential cavities 254. The circumferentialnodes 252 may extend proximally from the proximal abutment surface 214.The three circumferential cavities 254 can correspond to the number ofU-shaped members of the valve anchor that are housed within the proximalsheath component 204 between the proximal sheath component 204 and theproximal section 250 of the proximal enclosure 210.

This advantageous feature of some embodiments can allow the distalenclosure 212 to be properly positioned along the delivery device 200 inorder to ensure that distal enclosure 212 does not snag or become caughton any structure during retrieval of the delivery device 200.

As also shown in FIGS. 5A and 5B, the proximal and distal enclosures210, 212 can collectively house the support frame 102. The first andsecond core members 220, 222 can be actuated to separate the proximaland distal enclosures 210, 212, thereby permitting the support frame 102to self-expand when in position within the valve anchor 104.

For example, by pushing or pulling the first core member 220, the secondcore member 222, and/or the proximal sheath component 204 relative toeach other along the longitudinal axis of the delivery device 200, aclinician can control longitudinal movement of each of these componentsto permit the release of the support frame 102 and the valve anchor 104of the valve prosthesis 100.

Further, in some embodiments, to facilitate delivery of the deliverydevice 200 to the target location, as shown in FIGS. 5A and 5B, thesecond core member 222 can include a lumen 218 to permit the deliverydevice 200 to move along a guidewire, which can extend through the lumen218 of the second core member 222.

FIGS. 5A and 5B further illustrate positions of the proximal and distalenclosures 210, 212 during the release of the support frame 102. Afterseparating the proximal and distal enclosures 210, 212 from the positionillustrated in FIG. 5A to the position illustrated in FIG. 5A, the firstend portion 110 of the support frame 102 can begin to expand from thecompressed configuration to an expanded configuration. In someembodiments, the support frame 102 can have one or more anchors 109 (seealso FIG. 2) at its first end portion 110 that, when engaged with thenative valve structure can supplement the outward expansive force (dueto self-expansion of the support frame 102) and its resultant frictionalengagement, to mitigate downstream migration of the support frame 102relative to the native valve structure. Thus, by opening the first endportion 110 first (before the second end portion 112, and via relativemovement of the proximal and distal enclosures 210, 212), the first endportion 110 can “flower” out to facilitate release of the support frameand/or to engage with the native anatomy, such as the valve structureitself, to secure a longitudinal position of the support frame 102relative to the native valve structure. Thereafter, the second endportion 112 of the support frame 102 can be controlled and released tobecome disengaged and released from the proximal enclosure 210.

In some embodiments, the first end portion 110 and the second endportion 112 can open simultaneously, at the same or different rates. Forexample, in some embodiments, the first end portion 110 and the secondend portion 112 can open simultaneously, but with the first end portion110 opening at a faster rate than the second end portion 112.

Advantageously, the use of the proximal enclosure 210 and the distalenclosure 212 allows for greater control and enhanced operation of thesupport frame 102. For example, by controlling the position and rate ofseparation of the proximal enclosure 210 and the distal enclosure 212,the opening of the support frame 102 at both the first end portion 110and the second end portion 112 can be controlled. Further, bycontrolling the movement of the distal enclosure 212, the timing andrate of opening of the first end portion 110 can be controlled relativeto the timing and rate of opening of the second end portion 112 (whichmay be controlled by the movement of the proximal enclosure 210).

Additionally and advantageously, by having separate proximal and distalenclosures 210, 212, the delivery device 200 may experience reducedfrictional forces and minimize travel of the enclosures 210, 212relative to the support frame 102.

In particular, in accordance with some embodiments, the distal carrierassembly 206 can comprise a plunger mechanism 260 that can facilitateexpansion of the support frame 102. The plunger mechanism 260 can expandfrom a compressed state (shown in FIG. 5A) to an extended state (shownin FIG. 5A). The plunger mechanism 260 can be biased by a spring orother device in order to move automatically from the compressed state tothe extended state. However, the plunger mechanism 260 can also bemanually actuated by the clinician in some embodiments.

As illustrated, the plunger mechanism 260 can comprise a plunger head262 and a biasing means 264. The plunger head 262 can comprise a conicalor tapered proximal portion 286. The conical proximal portion 286 can beconfigured to not contact only the first end portion of the supportframe 102 during delivery, but can also help center a distal end portion290 of the tubular portion 282 of the proximal enclosure 210 relative toa longitudinal axis of the delivery device 200 and help align the distalend portion 290 with a proximal end portion 292 of the tubular portion272 of the distal enclosure 212. The plunger head 262 can also comprisean outer circumferential surface 294 that can contact not only an innersurface 296 of the tubular portion 272, but can also contact an innersurface 298 of the tubular portion 282 when the tubular portion 282 isdistally advanced over the conical proximal portion 286 of the plungerhead 262.

Further, the plunger mechanism 260 can be housed within a distal lumen270 of a tubular portion 272 of the distal enclosure 212. For example,the biasing means 264 may be a spring. The biasing means 264 can beinterposed between an interior structure or wall 274 of the distal lumen270 and a distal surface or structure 276 of the plunger head 262. Theplunger head 262 can move proximally within the distal lumen 270 inorder to continue to exert a proximally oriented force on the first endportion 110 of the support frame 102 until the support frame 102 exitsthe distal lumen 270. Thereafter, in accordance with some embodiments,the support frame 102 can self-expand until the second end portion 112is pulled out of a proximal lumen 280 of a tubular portion 282 of theproximal enclosure 210 as the support frame 102 continues to expand. Theexpanded state of the support frame 102 is illustrated in FIGS. 1 and 2,discussed above.

The present disclosure also describes various aspects of a deliverydevice for, e.g., transfemoral delivery of a valve prosthesis. Thedelivery device can support a valve prosthesis, such as the prosthesis100 discussed above. The delivery device can comprise a proximal sheathcomponent, a distal carrier assembly, and a control unit, wherein thedistal carrier assembly is distal to the proximal sheath component, andthe proximal sheath component is distal to the control unit. In someembodiments, the distal carrier assembly can comprise a conical ortapered end portion. The proximal sheath component and the distalcarrier assembly can at least partially enclose the support frame andthe valve anchor of the valve prosthesis prior to and during delivery ofthe valve prosthesis. The configuration of the delivery device withrespect to the proximal sheath component and the distal carrierassembly, the support frame, and the valve anchor can allow the valveanchor and the support frame to be loaded or positioned serially alongthe longitudinal axis in a compact condition, thus enabling the deliverydevice to achieve a minimal crossing profile to reduce any difficulty inadvancing the delivery device to the target location within the patient.The distance from which the valve anchor may be serially displaced fromthe support frame is highly variable. This may allow the user tominimize the radius of the delivery device which must be advancedthrough, for example, arteries and veins. Further, the valve anchor canbe expanded and positioned independent of the support frame prior topositioning and releasing the support frame, as described in greaterdetail below. Additionally, a link mechanism that interconnects thevalve anchor to the support frame can advantageously facilitate reliablepositioning of the support frame relative to the valve anchor.

Referring now to FIGS. 6-7D, the prosthesis 100 is illustrated loadedonto a delivery device 200. Using the delivery device 200, the valveprosthesis 100 can be delivered and expanded component by component inorder to achieve the expanded configuration illustrated in FIG. 2.During this component-by-component expansion process (illustrated in thedelivery stages of FIGS. 11A-11F of U.S. Patent Application No.62/781,537, filed on Dec. 18, 2018, noted above), the ability of thelink mechanism 160 to move along the U-shaped members of the valveanchor 104 provides several distinct benefits. For example, one of thesebenefits is illustrated in FIG. 6, which is that during delivery of thevalve prosthesis 100, it is advantageous to have the valve anchor 104positioned serially from the support frame 102 in order to achieve aminimal outer profile for the delivery device. This serial positioningallows the delivery device 200 to have a minimized outer diameter, whichcan allow the delivery device 200 to be more easily advanced throughblood vessels.

As shown in FIG. 6, the delivery device can carry the support frame, thevalve anchor, and the link mechanism of the valve prosthesis. Forexample, FIG. 6 shows that the delivery device 200 can carry the supportframe 102, the valve anchor 104, and the link mechanism 160 of the valveprosthesis 100. The delivery device 200 can comprise one or moreelongate core members that extend along a longitudinal axis of thedelivery device 200.

The delivery device 200 can also comprise a proximal sheath component204 (shown in dashed lines in FIG. 6 to illustrate the underlyingcomponents and features of the prosthesis 100 and the delivery device200) and a distal carrier assembly 206 (also shown in dashed lines inFIG. 6 to illustrate the underlying components and features of theprosthesis 100 and the delivery device 200). The proximal sheathcomponent 204 can be coupled to and extend distal to a control unit(illustrated in FIGS. 13A-13H of U.S. Patent Application No. 62/781,537,filed on Dec. 18, 2018, noted above), through which the clinician cancontrol movement of the various components of the delivery device 200.

The distal carrier assembly 206 can be a two-part component that isconfigured to house at least one of the valve anchor or the supportframe. The distal carrier assembly 206 comprise a proximal enclosure 210(shown in dashed lines) and a distal enclosure 212 (shown in dashedlines). The proximal enclosure 210 can be coupled to a first core member220, and the distal enclosure 212 can be coupled to a second core member222. In some embodiments, the distal enclosure 212 can be threadedlyand/or adhesively coupled or bonded to the second core member 222. Forexample, the second core member 222 may include a hollow shaft. Thefirst and second core members 220, 222 can allow a clinician tomanipulate the relative positions of the proximal and distal enclosures210, 212. Together, the proximal sheath component 204 and the distalcarrier assembly 206 can collectively house the valve anchor 104 and thesupport frame 102, respectively, during delivery of the valve prosthesis100 to a target location within the body (e.g., discussed herein as theaortic valve annulus) and be actuated by the clinician to position andrelease the valve prosthesis 100. Further, the distal enclosure 212 cancomprise a conical or tapered anterior or distal portion to facilitatemovement through the vasculature. In some embodiments, the distalcarrier assembly 206 can be referred to as a two-part distal enclosureor a split nose cone assembly. Optionally, the distal enclosure 212 cancomprise, be formed from, or include features that comprise a radiopaquematerial such as platinum.

FIG. 6 show the delivery device 200 prior to delivery of the prosthesis100, in a loaded configuration. As shown, the first and second coremembers 220, 222 extend through the delivery device 200 and are coupledat their distal ends to proximal and distal enclosures 210, 212,respectively, of the distal carrier assembly 206. As illustrated inthese figures, the second core member 222 can be disposed within a lumenof the first core member 220 and slidable therewithin. Accordingly, theproximal enclosure 210 of the distal carrier assembly 206, as well asthe proximal sheath component 204, can be slidable relative to thesecond core member 222 and the distal enclosure 212.

As also shown, the proximal sheath component 204 can extend distallyover the valve anchor 104 to enclose the valve anchor 104 within a lumenof the proximal sheath component 204 and maintain the valve anchor 104in a compressed state. The lumen of the proximal sheath component 204may also be referred to as a proximal sheath lumen. The proximal sheathcomponent 204 can be retracted relative to the valve anchor 104 in orderto permit the base portions of the U-shaped members of the valve anchor104, thereafter to expand and later be maneuvered into position withinthe aortic sinuses.

As also illustrated in FIG. 6 (see also FIGS. 3A-3C of U.S. PatentApplication No. 62/781,537, filed on Dec. 18, 2018, noted above), thedelivery device 200 can comprise at least one grasper 224 that canengage with and control positioning of the valve anchor 104. The grasper224 can comprise distal ends, pinchers, or hooks 226 at its distal endthat can be coupled to the peak portions of the U-shaped members of thevalve anchor 104. For example, the pinchers 226 of the grasper 224 canbe coupled to the anchor retention component 170 at the engagement areaof the valve anchor 104 to cause the grasper 224 to be engaged with thevalve anchor 104. The number of graspers 224 preferably equals thenumber of engagement areas 150 or U-shaped members 140 of the valveanchor 104. Each of the graspers 224 can comprise a tubular enclosure228 through which a pair of wires, which terminate in the pinchers orhooks 226, passes. The wires can be pulled proximally relative to thetubular enclosure 228 in which the wires are housed in order to tightenthe pinchers 226 around the anchor retention component 170, thusengaging the valve anchor 104. In order to release the pinchers 226, thewires can be shifted distally relative to the tubular enclosure 228thereby allowing the pinchers 226 to spring open radially and releasethe anchor retention component 170. The distal end of each of thegraspers 224 can enclose or be coupled to a hook of the valve anchor104.

The interconnection between the distal ends, pinchers, or hooks 226 ofthe graspers 224 and the valve anchor 104 can permit the valve anchor104 of the support frame 102 to be held in a stationary and/orcompressed position relative to or within the proximal sheath component204. As discussed further below, for example, with regard to FIGS.9A-9C, this engagement can maintain the engagement areas 150 in a commonplane 152, oriented generally perpendicular relative to the longitudinalaxis of the delivery device 200. Additionally, when the proximal sheathcomponent 204 is proximally retracted relative to the distal ends of thegraspers 224, the valve anchor 104 can begin to expand; however, theengagement between the graspers 224 and the engagement areas 150 canallow a clinician to push, pull, or rotate the valve anchor relative tothe delivery device 200 before fully releasing the valve anchor 104 fromengagement with the delivery device 200. For example, this can allow theclinician to rotate or push the base portions 144 of the valve anchor104 into the nested position within the aortic sinuses, as discussedabove. Thereafter, once in the nested position, the engagement areas 150of the valve anchor 104 can be released from the pinchers 226 of thegraspers 224, and the valve anchor 104 can fully expand and be releasedinto apposition with the native valve annulus.

Accordingly, in at least one embodiment, a clinician can manipulate thevalve anchor by engaging or coupling an engagement portion or protrusionof a grasper with a clasper tang of a valve anchor. The engagementportion and the clasper tang can be restricted from relative radialmovement (to thereby remain longitudinally engaged and secured relativeto each other) by enclosing the engagement portion and the clasper tangwithin a tubular enclosure. In order to disengage the engagement portionand the clasper tang, the clinician can relatively advance theengagement portion distally beyond an end of the tubular enclosure. Oncein this position, the clasper tang can tend to be pulled radiallyoutwardly as the valve anchor expands radially, thereby disengaging theclasper tang from the engagement portion. Thereafter, the engagementportion can be retracted or withdrawn into the tubular enclosure. Insome embodiments, the engagement portion engages a window or protrusionof the clasper tang. In some embodiments, the engagement portion is apin or slot. In some embodiments, each grasper can include a pluralityof engagement portions or protrusions.

During use, after the valve anchor has been released from within theproximal sheath and after the valve anchor and the valve frame have beenreleased from the delivery device, the delivery device can be configuredto be compactly reassembled and withdrawn into the introducer sheath inorder to minimize any damage to the blood vessel through which thedelivery device was advanced.

For example, in at least one embodiment, as illustrated in FIG. 7A, theproximal enclosure 210 can comprise a proximal section 250 to facilitaterealignment (e.g., radial realignment) of the distal end portion 208 ofthe proximal sheath component 204 with the proximal enclosure 210.

As illustrated in FIG. 7A, the proximal section 250 can be coupled tothe core member 220. Further, the proximal section 250 can optionally beconical or tapered in a proximal direction and/or have circumferentialnodes 252 and/or circumferential cavities 254 that can facilitaterealignment of the proximal sheath component 204 relative to theproximal enclosure 210 along a longitudinal axis of the delivery device200. The tapering of the proximal section 250 can allow the distal endportion 208 of the proximal sheath component 204 to smoothly advancedistally over the proximal section 250, and the circumferential nodes252 can contact an inner surface of the distal end portion 208 of theproximal sheath component 204 as the distal end portion 208 approachesthe proximal abutment surface 214.

For example, as illustrated in FIG. 7A, the circumferential nodes 252may gradually taper from the proximal abutment surface 214 in theproximal direction. With such a configuration, as the proximal sheathcomponent 204 slides distally toward the proximal enclosure 210, thecircumferential nodes 252 can advantageously guide the distal endportion 208 of the proximal sheath component 204 distally toward theproximal abutment surface 214 of the proximal enclosure 210 so that theouter surface of the proximal sheath component 204 is aligned with anouter surface of the proximal enclosure 210. Thus, the outer surfaces ofthe proximal enclosure 210 and the proximal sheath component 204 canprovide a smooth outer profile for the delivery device 200 that canadvantageously reduce the likelihood that the delivery device 200catches or otherwise damages tissue within a body lumen as the deliverydevice 200 is moved therewithin.

Optionally, the proximal section 250 can comprise three circumferentialnodes 252 and three circumferential cavities 254. The circumferentialnodes 252 may extend proximally from the proximal abutment surface 214.The three circumferential cavities 254 can correspond to the number ofU-shaped members of the valve anchor that are housed within the proximalsheath component 204 between the proximal sheath component 204 and theproximal section 250 of the proximal enclosure 210.

This advantageous feature of some embodiments can allow the distalenclosure 212 to be properly positioned along the delivery device 200 inorder to ensure that distal enclosure 212 does not snag or become caughton any structure during retrieval of the delivery device 200.

As also shown in FIGS. 6-7B, the proximal and distal enclosures 210, 212can collectively house the support frame 102. The first and second coremembers 220, 222 can be actuated to separate the proximal and distalenclosures 210, 212, thereby permitting the support frame 102 toself-expand when in position within the valve anchor 104.

For example, by pushing or pulling the first core member 220, the secondcore member 222, and/or the proximal sheath component 204 relative toeach other along the longitudinal axis of the delivery device 200, aclinician can control longitudinal movement of each of these componentsto permit the release of the support frame 102 and the valve anchor 104of the valve prosthesis 100.

Further, in some embodiments, to facilitate delivery of the deliverydevice 200 to the target location, as shown in FIGS. 7A-7D, the secondcore member 222 can include a lumen 218 to permit the delivery device200 to move along a guidewire, which can extend through the lumen 218 ofthe second core member 222.

FIGS. 7A-7D further illustrate positions of the proximal and distalenclosures 210, 212 during the release of the support frame 102. Afterseparating the proximal and distal enclosures 210, 212 from the positionillustrated in FIG. 7A to the position illustrated in FIG. 7B, the firstend portion 110 of the support frame 102 can begin to expand from thecompressed configuration to an expanded configuration. In someembodiments, the support frame 102 can have one or more anchors 109 (seealso FIG. 2) at its first end portion 110 that, when engaged with thenative valve structure can supplement the outward expansive force (dueto self-expansion of the support frame 102) and its resultant frictionalengagement, to mitigate downstream migration of the support frame 102relative to the native valve structure. Thus, by opening the first endportion 110 first (before the second end portion 112, and via relativemovement of the proximal and distal enclosures 210, 212), the first endportion 110 can “flower” out to facilitate release of the support frameand/or to engage with the native anatomy, such as the valve structureitself, to secure a longitudinal position of the support frame 102relative to the native valve structure. Thereafter, the second endportion 112 of the support frame 102 can be controlled and released tobecome disengaged and released from the proximal enclosure 210.

In some embodiments, the first end portion 110 and the second endportion 112 can open simultaneously, at the same or different rates. Forexample, in some embodiments, the first end portion 110 and the secondend portion 112 can open simultaneously, but with the first end portion110 opening at a faster rate than the second end portion 112.

Advantageously, the use of the proximal enclosure 210 and the distalenclosure 212 allows for greater control and enhanced operation of thesupport frame 102. For example, by controlling the position and rate ofseparation of the proximal enclosure 210 and the distal enclosure 212,the opening of the support frame 102 at both the first end portion 110and the second end portion 112 can be controlled. Further, bycontrolling the movement of the distal enclosure 212, the timing andrate of opening of the first end portion 110 can be controlled relativeto the timing and rate of opening of the second end portion 112 (whichmay be controlled by the movement of the proximal enclosure 210).

Additionally and advantageously, by having separate proximal and distalenclosures 210, 212, the delivery device 200 may experience reducedfrictional forces and minimize travel of the enclosures 210, 212relative to the support frame 102.

In particular, in accordance with some embodiments, the distal carrierassembly 206 can comprise a plunger mechanism 260 that can facilitateexpansion of the support frame 102. The plunger mechanism 260 can expandfrom a compressed state (shown in FIG. 7A) to an extended state (shownin FIG. 7B). The plunger mechanism 260 can be biased by a spring orother device in order to move automatically from the compressed state tothe extended state. However, the plunger mechanism 260 can also bemanually actuated by the clinician in some embodiments.

As illustrated, the plunger mechanism 260 can comprise a plunger head262 and a biasing means 264. Further, the plunger mechanism 260 can behoused within a distal lumen 270 of a tubular portion 272 of the distalenclosure 212. For example, the biasing means 264 may be a spring. Thebiasing means 264 can be interposed between an interior structure orwall 274 of the distal lumen 270 and a distal surface or structure 276of the plunger head 262. The plunger head 262 can move proximally withinthe distal lumen 270 in order to continue to exert a proximally orientedforce on the first end portion 110 of the support frame 102 until thesupport frame 102 exits the distal lumen 270. Thereafter, in accordancewith some embodiments, the support frame 102 can self-expand until thesecond end portion 112 is pulled out of a proximal lumen 280 of atubular portion 282 of the proximal enclosure 210 as the support frame102 continues to expand. The expanded state of the support frame 102 isillustrated in FIGS. 7C and 7D.

Some embodiments can also provide self-aligning features to allow thecomponents of the delivery assembly to be moved from a releasing state(where the components of the valve prosthesis are released fromengagement with the delivery assembly) to a nested or stowed state inwhich the delivery assembly has an aligned outer surfaces or outersurfaces that abut at a seam outer profile that can tend to reduce thelikelihood of snagging on the vasculature as the delivery assembly isretrieved from the patient's vasculature. For example, optionally, afterthe support frame 102 has been expanded and released from the distalcarrier assembly 206, the plunger head 262 can advantageously facilitaterepositioning and realignment of the proximal and distal enclosures 210,212 of the distal carrier assembly 206 in preparation for removal of thedelivery device 200 from the patient.

For example, the plunger head 262 can comprise a conical or taperedproximal portion 286. The conical proximal portion 286 can be configuredto not contact only the first end portion of the support frame 102during delivery, but can also help center a distal end portion 290 ofthe tubular portion 282 of the proximal enclosure 210 relative to alongitudinal axis of the delivery device 200 and help align the distalend portion 290 with a proximal end portion 292 of the tubular portion272 of the distal enclosure 212.

Further, in some embodiments, the plunger head 262 can extend proximallyat least partially out of or from the tubular portion 272 of the distalenclosure 212. For example, the plunger head 262 can comprise an outercircumferential surface 294 that can contact not only an inner surface296 of the tubular portion 272, but can also contact an inner surface298 of the tubular portion 282 when the tubular portion 282 is distallyadvanced over the conical proximal portion 286 of the plunger head 262.As such, distal end portion 290 of the proximal enclosure 210 canpositioned in an abutting contact position 299 with the proximal endportion 292 of the distal enclosure 212, as shown in FIG. 7D. Thus, theplunger mechanism 260 can facilitate not only be expansion of thesupport frame 102, but can also facilitate the self-alignment andrepositioning of the proximal and distal enclosures 210, 212 in order toensure that neither the proximal enclosure 210 nor the distal enclosure212 snags or becomes caught on any structure during retrieval of thedelivery device 200.

In accordance with at least one embodiment disclosed herein, thedelivery device can optionally comprise a plunger mechanism havingfeatures that can expand radially beyond the outer diameter of thetubular portion 272 of the distal enclosure 212. Further, the plungermechanism can also be configured in a manner to engage a proximal end ofthe tubular portion 272 of the distal enclosure 212. Thus, instead ofthe plunger mechanism 260 illustrated in the embodiment shown in FIGS.7A-7D, the delivery device can optionally comprise a nose cone protectorthat can facilitate expansion of the support frame and advantageouslyprovide a contact surface or ramp that tapers from a first diameter to asecond, larger diameter in a distal direction to avoid or reduce anycatching or engagement of the delivery device 200 when being proximallywithdrawn into the delivery catheter. Further, the nose cone protectorcan increase the column strength of the nose cone or the distal carrierassembly 206. In this manner, the nose cone protector can help avoidbreakage or dislocation of the nose cone or distal carrier assembly 206when the clinician is exerting a proximal retraction force on thedelivery assembly 200 to retract the delivery device 200 into thedelivery catheter.

For example, FIGS. 8A-8F illustrate a nose cone protector 260 a that canfacilitate expansion of the support frame 102, similar to the plungermechanism 260 illustrated in FIGS. 7A-7D. The nose cone protector 260 acan move longitudinally from a compressed state (shown in FIG. 8B) to anextended state (shown in FIG. 8C). The nose cone protector 260 a can bebiased by a spring or other device in order to move automatically fromthe compressed state to the extended state. However, the nose coneprotector 260 a can also be manually actuated by the clinician, in someembodiments.

As shown in FIG. 8A, the nose cone protector 260 a can comprise aplunger head 262 a having petals 263 that each extend radially from thenose cone protector 260 a and comprise ramped surfaces 263 a. The rampedsurfaces 263 a can be configured to engage a distal end of the supportframe 102 and urge the support frame 102 out of the distal enclosure212, similar to the plunger mechanism 260 discussed above, which canfacilitate expansion of the support frame 102. In some embodiments, thenose cone protector 260 a can comprise polyether ether ketone (PEEK) orother thermoplastics.

In at least one embodiment, the petals 263 can be configured to deflectradially inwardly while the nose cone protector 260 a is positionedwithin the lumen of the distal enclosure 212, but to expand radiallyoutwardly when at least a portion of the petals 263 exits the distalenclosure 212, as discussed below. Thus, the petals 263 can beresiliently biased toward a radially expanded position.

Additionally, the nose cone protector 260 a can comprise a central lumen261 a through which the core member 220 of the delivery device 200 canextend. In this regard, the nose cone protector 260 a can be permittedto slide along the core member of the delivery device.

Further, the nose cone protector 260 a can be used with the distalcarrier assembly 206 to ensure that neither the proximal enclosure 210nor the distal enclosure 212 snags or becomes caught on the deliverycatheter or any anatomical structure during retrieval of the deliverydevice 200. In at least one embodiment, the ramped surfaces 263 a of thenose cone protector 260 a can also facilitate self-alignment andrepositioning of the proximal and distal enclosures 210, 212 similar tothat provided by the plunger mechanism 260.

In use, because the nose cone protector 260 a provides a smooth, rampedsurface that the delivery device 200 can contact against anyprotuberances of the anatomical structure or delivery catheter, the nosecone protector 260 a can thereby advantageously minimize the pulling orretraction force required by the clinician during retraction of thedelivery device 200 into the delivery catheter. Of course, anotherbeneficial effect of the nose cone protector 260 a is to prevent orreduce any trauma to the blood vessel.

As illustrated, the nose cone protector 260 a can be biased to springradially outward to engage against the proximal end of the distalenclosure 212 in its extended state. In the extended state, the petals263 can spread apart at separations 267 a. Further, the petals 263 caneach comprise an engagement tooth 266 a that has an outer surface thatis radially offset from an outer surface of its respective petal 263,thereby permitting the petal 263 to expand radially beyond an innerdiameter of the distal enclosure 212. The teeth 266 a can have a contactsurface that is radially offset from an outer surface of the petals 263.Further, when the teeth 266 engage the proximal end of the distalenclosure 212, the outer surfaces of the petals 263 can extend radiallybeyond the outer surface of the distal enclosure 212.

In some embodiments, a distal engagement surface 265 a of each petal 263can abut the proximal end of the distal enclosure 212. As illustrated,the ramped surface 263 a of the nose cone protector 260 a can align andfacilitate repositioning of the proximal and distal enclosures 210, 212relative to each other in anticipation of proximally withdrawing thedelivery device 200 into the delivery catheter 530. Additionally, theramped surface 263 a of the nose cone protector 260 a can provide anangled surface that will not tend to snag or engage a distal end 531 ofthe delivery catheter 530 (see FIG. 8F).

As illustrated in FIG. 8B, the nose cone protector 260 a can be housedwithin a distal lumen 270 of a tubular portion 272 of the distalenclosure 212. The nose cone protector 260 a can be coupled to and urgedproximally out of the distal enclosure 212 via a biasing means 264. Asdescribed with respect to the plunger mechanism 260, the biasing means264 may be a spring. The petals 263 can be radially compressed to behoused within the distal lumen 270. The biasing means 264 can beinterposed between an interior structure or wall 274 of the distal lumen270 and a distal surface or structure 276 of the plunger head 262 a. Theplunger head 262 a can move proximally within the distal lumen 270 inorder to continue to exert a proximally oriented force on the first endportion 110 of the support frame 102 until the support frame 102 exitsthe distal lumen 270. Thereafter, in accordance with some embodiments,the support frame 102 can self-expand until the second end portion 112is pulled out of a proximal lumen 280 of a tubular portion 282 of theproximal enclosure 210 as the support frame 102 continues to expand. Theexpanded state of the support frame 102 is illustrated in FIGS. 8C-8F.

As illustrated in FIGS. 8C and 8D, as the nose cone protector 260 aadvances (FIG. 8C shows the nose cone protector 260 a in a semi-expandedstate) and the distal engagement surface 265 a extends past the proximalend of the distal lumen 270 (FIG. 8D shows the nose cone protector 260 ain a fully expanded state), the petals 263 can radially expand to engageagainst the distal lumen 270. Optionally, the proximal end of the nosecone protector 260 a can be axially retained by collar engaged againstthe central lumen 261 a to maintain the distal engagement surface 265 ain axial abutment with the proximal end of the distal enclosure 212.

In addition to contacting the first end portion of the support frame 102during delivery, as shown in FIG. 8E, the ramped surface 263 a can alsohelp center a distal end portion 290 of the tubular portion 282 of theproximal enclosure 210 relative to a longitudinal axis of the deliverydevice 200 and help align the distal end portion 290 with a proximal endportion 292 of the tubular portion 272 of the distal enclosure 212.

Further, as shown in FIG. 8F, in some embodiments, the ramped surface263 a allows the proximal sheath component 204 to be concentricallyaligned with the distal enclosure 212, minimizing the retraction forcerequired to retract the proximal and distal enclosure 210, 212 into theproximal sheath component. In some embodiments, the ramped surface 263 acan have a ramp angle of approximately 45 degrees, or may range frombetween about 10 degrees to about 80 degrees, from between about 20degrees to about 70 degrees, from between about 30 degrees to about 60degrees, or from between about 40 degrees to about 50 degrees.

FIGS. 9A-9C illustrate optional aspects of a delivery device, accordingto at least one embodiment. These figures do not illustrate all of thecomponents of the delivery device that can be incorporated into anembodiment. However, the features illustrated in these figures can beincorporated into embodiments of the delivery device to facilitateengagement with the valve anchor and/or facilitate delivery and controlof the valve anchor during implantation and release of the valve anchorat the target location.

In accordance with at least one embodiment disclosed herein is therealization that when the delivery device is moved through a bloodvessel, the delivery device may be bent or curved as it passes through atortuosity of the blood vessel. When this happens, the graspers may tendto move radially within the proximal sheath component, which may causethe distal or engagement ends of the graspers to become longitudinallydisplaced or misaligned relative to each other. This may cause bendingor misalignment of the valve anchor during delivery, which may makeplacement more challenging.

More specifically, in at least one embodiment, the grasper mechanismsmay extend from a handle actuator (see e.g., FIGS. 13A-13H of U.S.Patent Application No. 62/781,537, filed on Dec. 18, 2018, noted above)from a common plane (that may be oriented generally perpendicularrelative to a longitudinal axis of the delivery device) and haveapproximately equal longitudinal lengths. Additionally, each of thegrasper mechanisms may originate from a given radial or circumferentialposition, sector, or quadrant within the proximal sheath component. Ifthe delivery device extends along a straight path, the distal orengagement ends of the graspers will also be aligned in a common planethat is oriented generally perpendicular relative to the longitudinalaxis of the delivery device thereby engaging with the areas of the valveanchor, as shown in FIG. 5 of U.S. Patent Application No. 62/781,537,filed on Dec. 18, 2018, noted above.

However, in use, if the proximal sheath component bends (as shown inFIG. 9A), e.g., due to a tortuosity of the blood vessel, each of thegrasper mechanisms may be moved out of its original circumferential orradial position, sector, or quadrant within the proximal sheathcomponent. This occurs because each individual grasper mechanism willtend to extend in a straight, linear path within the proximal sheathcomponent and only bend if the grasper mechanism hits the inner wall ofthe proximal sheath component. As a result, the grasper mechanisms mayconverge against an outer wall of a bend in the proximal sheathcomponent, which can change the relative positioning of the distal orengagement ends of the graspers. Accordingly, instead of being alignedor positioned within a common plane that is oriented generallyperpendicular relative to a longitudinal axis of the proximal sheathcomponent, the distal or engagement ends of the graspers may bepositioned out of plane or simply out of the common plane that extendsperpendicular relative to the longitudinal axis of the proximal sheathcomponent. Such a misalignment can create stress, misalignment,unintentional disengagement, or bending of the valve anchor, whoseengagement areas are most preferably maintained within a common plane(that is oriented generally perpendicular relative to a longitudinalaxis of the proximal sheath component) during delivery.

Therefore, at least one embodiment can be configured to include analignment hub that can maintain or fix a longitudinal position of atleast a portion of the grasper mechanisms along distal portion of thegrasper mechanisms. In this manner, although intermediate portions ofthe grasper mechanisms may be radially misaligned or displaced fromtheir original radial or circumferential position, sector, or quadrantwithin the proximal sheath component, the alignment hub canadvantageously serve to reset or realign the positions of the graspermechanisms so that the longitudinal positions of the can be locatedwithin substantially the same or common plane positioned perpendicularlyrelative to a longitudinal axis of the proximal sheath component.

For example, FIGS. 9A-9C illustrate a distal hub or grasper alignmenthub 230 that may optionally be used in at least one embodiment of thedelivery device. As illustrated, the grasper alignment hub 230 can beutilized to fix or maintain the distal ends of the graspers 226 a in adesirable common plane to allow for desired and/or predictableengagement and disengagement of the graspers 226 a with the valve anchor104. In particular, the grasper alignment hub 230 can allow the distalends of the graspers 226 a to be maintained in a common plane despitebending of a proximal sheath component 204 530 as is manipulated throughor past tortuosities of a blood vessel, e.g., at a bend.

As illustrated in FIGS. 9A and 9B, the grasper alignment hub 230 can bebonded or secured relative or directly to the tubular enclosures 228 aof the graspers 226 a near the distal section of the delivery device. Insome embodiments, the grasper alignment hub 230 can be secured to thetubular enclosures 228 a at least approximately 1 inch, 2 inches, 3inches, 3.5 inches, or 4 inches from the distal end of the deliverydevice.

Referring to FIG. 9B, the graspers 226 a and the corresponding tubularenclosures 228 a extend through the grasper alignment hub 230, between afirst or proximal end 236 to a second or distal end 238 through tubularenclosure passages 232 formed through the grasper alignment hub 230. Thetubular enclosures 228 a can be bonded or mechanically coupled to thetubular enclosure passages 232 so as to engage or secure the tubularenclosures 228 a relative to the grasper alignment hub 230. Even thoughthe tubular enclosures 228 a may be constrained from longitudinalmovement along the distal section of the delivery device relative to thegrasper alignment hub 230, in some embodiments, the graspers 226 a maystill be permitted to move within the tubular enclosures 228 a tofacilitate engagement and/or disengagement with the valve anchor.However, because the tubular enclosures 228 a are constrained fromsliding movement, the distal ends of the graspers 226 a may also berestricted from being longitudinally displaced relative to each otherwhen the proximal sheath component 204 moves through or is moved into acurve or tortuosity. tend to be longitudinally displaced relative toeach other less than in an embodiment

As illustrated, the core member 220 can pass through the first orproximal end 236 to the second or distal end 238 through a core memberpassage 234 formed through the grasper alignment hub 230. The coremember 220 can be movable through the core member passage 234. Forexample, in some embodiments, the grasper alignment hub 230 can moverelative to the core member 220 while the tubular enclosures 228 a aresecured to the grasper alignment hub 230.

Referring to FIG. 9C, the outer surface 239 of the grasper alignment hub230 can have a generally cylindrical shape. In some embodiments, thecylindrical shape of the outer surface 239 can allow the grasperalignment hub 230 to move freely within the catheter 530. Asillustrated, the tubular enclosure passages 232 and the core memberpassage 234 can be arranged to maintain a desired alignment between thetubular enclosures 228 a and the core member 220 as the catheter 530 ismanipulated during introduction and delivery. Further, in at least oneembodiment, the cross-sectional arrangement of the tubular enclosurepassages 232 and the core member 220 at the grasper alignment hub 230can be substantially similar to their cross-sectional arrangement at thehandle actuator.

Additionally, in accordance with at least one embodiment, thearrangement of the tubular enclosure passages 232 and the core memberpassage 234 and the grasper alignment hub 230 can further reduce oravoid twisting or misalignment of the tubular enclosures 228 a and thecore member 220 relative to the longitudinal axis of the lumen of thecatheter 530.

As illustrated, in at least one embodiment, the tubular enclosurepassages 232 may be disposed adjacent to each other, offset from acentral axis of the grasper alignment hub 230, along an arc bordering aperiphery of the grasper alignment hub 230. The core member passage 234can have a cross-sectional diameter larger than the respectivecross-sectional diameters of the tubular enclosure passages 232. Thecore member passage 234 can be offset from the central axis of thegrasper alignment hub 230 and be spaced apart from the tubular enclosurepassages 232. Such a configuration can allow the grasper alignment hub232 have a minimal cross-sectional diameter while permitting each of thetubular enclosure passages 232 and the core member passage 234 to becircumscribed therewithin.

However, in at least one embodiment, the tubular enclosure passages 232may be disposed circumferentially around the core member passage 234.Optionally, the tubular enclosure passages 232 may be equidistantlydisposed.

Referring to FIGS. 7E, 10A, and 10B, the proximal section 250 of theproximal enclosure 210 can include features that facilitate engagementand alignment of the proximal section 250 with the valve anchor. Asillustrated in FIGS. 7E and 10A, the proximal section 250 of theproximal enclosure 210 has circumferential nodes 252 and circumferentialcavities 254. Each of the circumferential cavities 254 may be defined bya space between two of the circumferential nodes 252. As illustrated inFIG. 10B, respective U-shaped members of the valve anchor 104 may bereceived in the circumferential cavities 254, between thecircumferential nodes 252.

For example, when the valve anchor 104 is loaded and the proximal sheathcomponent 204 covers the valve anchor 104, each U-shaped member of thevalve anchor 104 may be positioned in a corresponding circumferentialcavity 254, between the proximal section 250 and the proximal sheathcomponent 204. The cross-sectional of the proximal section 250 of theproximal enclosure 210 illustrated in FIG. 7E (taken along lines 7E-7Eof FIG. 7D) also shows that each of the circumferential cavities 254 maybe defined by a space between two of the circumferential nodes 252, suchthat the valve anchor 104 may be received or positioned in thecircumferential cavities 254.

The circumferential nodes 252 and the circumferential cavities 254 mayfacilitate realignment of the proximal sheath component 204 relative tothe proximal enclosure 210 along a longitudinal axis of the deliverydevice 200. The proximal section 250 may be conical or tapered in aproximal direction, thereby facilitating alignment of the proximalsheath component 204 relative to the proximal enclosure 210 along alongitudinal axis of the delivery device 200. In the examplesillustrated in FIGS. 7E, 10A, and 10B, the proximal section 250 hasthree circumferential nodes 252 and three circumferential cavities 254.However, in another example, a different number of the circumferentialnodes 252 and/or a different number of the circumferential cavities 254may be implemented.

As discussed above, the delivery device 200 provide several benefits,such as a compact passing profile that allows the delivery device 200 tomove through the vasculature with facility, reliable control andpositioning of the valve anchor while for within the native valveannulus and sinuses, predictable relative positioning of the supportframe 102 and the valve anchor 104 via the link mechanism 160, andsnag-free retrieval of the delivery device 200.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as clausesets having numbered clauses (1, 2, 3, etc.) for convenience. These areprovided as examples, and do not limit the subject technology.Identifications of the figures and reference numbers are provided belowmerely as examples and for illustrative purposes, and the clauses arenot limited by those identifications.

Clause Set 1: Features of a Valve Prosthesis Delivery Device

Clause 1. A valve prosthesis delivery device for delivering a valveprosthesis, the valve prosthesis comprising a valve frame and a valveanchor, the delivery device comprising: an elongate core memberextending along a longitudinal axis of the system; a proximal sheathcomponent slidably coupled to the core member and comprising a proximalsheath lumen, the proximal sheath component being configured to receiveat least a portion of the valve anchor within the proximal sheath lumen,the proximal sheath being proximally retractable relative to the coremember for permitting expansion of the valve anchor; and a distalcarrier assembly comprising a distal enclosure and a proximal enclosure,the distal enclosure being coupled to the core member and comprising adistal lumen, the distal enclosure being configured to receive a distalportion of the valve frame within the distal lumen in a compressedconfiguration, the proximal enclosure being coupled to the core memberproximal to the distal enclosure and comprising a proximal lumen, theproximal enclosure being configured to receive a proximal portion of thevalve frame within the proximal lumen in a compressed configuration.

Clause 2. The delivery device of Clause 1, further comprising a plungermechanism and a biasing means disposed within the distal lumen of thedistal carrier assembly, the plunger mechanism being moveable between adistal position and a proximal position within the distal lumen, theplunger mechanism being biased toward the proximal position by thebiasing means for urging the valve frame out of the distal lumen.

Clause 3. The delivery device of Clause 2, wherein the plunger mechanismcomprises a plunger head that is moveable between the distal positionand the proximal position within the distal lumen, the plunger headbeing biased toward the proximal position by the biasing means.

Clause 4. The delivery device of Clause 3, wherein in the proximalposition, the plunger head extends at least partially proximally out ofthe distal lumen.

Clause 5. The delivery device of Clause 3, wherein in the proximalposition, an outer surface of the plunger head is in contact with boththe inner surface of the distal lumen and an inner surface of theproximal lumen when the proximal enclosure is distally advanced over theplunger head.

Clause 6. The delivery device of Clause 3, further comprising the valveprosthesis, wherein when the valve frame is positioned within the distallumen, the plunger head is urged to the distal position.

Clause 7. The delivery device of Clause 3, wherein the biasing meanscomprises a spring.

Clause 8. The delivery device of Clause 7, wherein the biasing meanscomprises a spring, the spring being interposed between a proximal faceof the distal enclosure and a distal face of the plunger head.

Clause 9. The delivery device of Clause 2, wherein the plunger mechanismcomprises a proximal portion that tapers in a proximal direction.

Clause 10. The delivery device of Clause 9, wherein the proximal portioncomprises a conical shape.

Clause 11. The delivery device of Clause 9, wherein in the proximalposition, the plunger mechanism extends at least partially proximallyout of the distal lumen, the proximal enclosure being distallyadvanceable over the tapered proximal portion of the plunger mechanismto align an outer surface of the distal enclosure with an outer surfaceof the proximal enclosure for facilitating removal of the deliverydevice from a patient.

Clause 12. The delivery device of any preceding Clause, wherein thedistal enclosure comprises a distal nose cone that tapers in a distaldirection.

Clause 13. The delivery device of any preceding Clause, furthercomprising the valve prosthesis, wherein in a loaded configuration, aproximal end of the distal enclosure is spaced longitudinally apart froma distal end of the proximal enclosure to permit a longitudinal sectionof the valve frame to remain exposed in the loaded configuration.

Clause 14. The delivery device of any preceding Clause, furthercomprising the valve prosthesis.

Clause 15. The delivery device of any preceding Clause, wherein theproximal enclosure comprises a proximal section having an outer diametersmaller than an inner diameter of the proximal lumen, and wherein when avalve anchor is loaded onto the delivery device, the valve anchorextends between the proximal section and the proximal sheath in a loadedconfiguration.

Clause 16. The delivery device of Clause 15, wherein the proximalsection tapers in a proximal direction.

Clause 17. The delivery device of Clause 15, wherein the proximalsection has a plurality of circumferential nodes, the plurality ofcircumferential nodes extending proximally from a proximal abutmentsurface of the proximal enclosure.

Clause 18. The delivery device of Clause 17, wherein the plurality ofcircumferential nodes comprises three circumferential nodes that areevenly circumferentially spaced apart from each other.

Clause 19. The delivery device of Clause 17, wherein the valve anchorcomprises a plurality of U-shaped members, and wherein the proximalsection has a plurality of circumferential cavities each configured toreceive a respective U-shaped member of the valve anchor when the valveanchor is loaded onto the delivery device in a compressed configuration.

Clause 20. The delivery device of Clause 19, wherein, when the valveanchor is loaded onto the delivery device, each of the U-shaped membersis positioned adjacent to a respective one of the plurality ofcircumferential cavities between the proximal section and the proximalsheath component.

Clause 21. The delivery device of Clause 20, wherein in a deliveryconfiguration, the proximal enclosure is spaced apart from the distalenclosure by a gap to permit a portion of the valve frame to be exposedthrough the gap.

Clause 22. The delivery device of Clause 21, wherein the valveprosthesis includes a link mechanism interconnecting the valve anchorand the valve frame, and wherein the link mechanism extends through thegap, the link mechanism being moveable relative to the valve frame afterreleasing the valve anchor from the proximal sheath component.

Clause 23. A valve prosthesis delivery device for delivering a valveprosthesis, the valve prosthesis comprising a valve frame and a valveanchor, the delivery device comprising: an elongate core memberextending along a longitudinal axis of the system; a sheath componentslidably coupled to the core member and comprising a sheath lumen, thesheath component being configured to receive at least a portion of thevalve anchor within the sheath lumen, the sheath being moveable relativeto the core member for permitting expansion of the valve anchor; and acarrier assembly comprising a distal enclosure and a proximal enclosure,the enclosure being coupled to the core member and comprising a distallumen, the enclosure being configured to receive a distal portion of thevalve frame within the distal lumen in a compressed configuration, theproximal enclosure being coupled to the core member proximal to theenclosure and comprising a proximal lumen, the proximal enclosure beingconfigured to receive a proximal portion of the valve frame within theproximal lumen in a compressed configuration.

Clause 24. The delivery device of Clause 23, wherein the sheathcomponent is positioned proximally relative to the carrier assembly.

Clause 25. The delivery device of Clause 23, comprising any of thefeatures recited in any of Clauses 1-21.

Clause 26. A method for delivering a prosthetic heart valve prosthesisto a native valve structure of a patient, the valve prosthesiscomprising a valve frame and a valve anchor, the method comprising:introducing the valve prosthesis into the patient at an implantationsite via a valve prosthesis delivery device, the system comprising aproximal sheath component and a distal carrier assembly, the proximalsheath component receiving at least a portion of the valve anchor in aproximal sheath lumen, and the distal carrier assembly comprising adistal enclosure and a proximal enclosure, the distal enclosure beingconfigured to receive at least a distal portion of the valve frame;proximally retracting the proximal sheath in a proximal direction topermit expansion of the valve anchor; and expanding the distal carrierassembly to permit expansion of the valve frame.

Clause 27. The method of Clause 26, further comprising distally urging abase portion of the valve anchor into engagement with a native valvestructure.

Clause 28. The method of Clause 26 or 27, further comprising proximallyretracting the valve frame relative to the valve anchor to engage a linkmechanism therebetween and restricting a range of movement of the valveframe relative to the valve anchor.

Clause 29. The method of Clause 28, further comprising distallyadvancing the valve frame.

Clause 30. The method of Clause 26, wherein the expanding longitudinallyseparating the distal enclosure from the proximal enclosure to permitexpansion of the distal portion of the valve frame.

Clause 31. The method of Clause 26-30, wherein the expanding comprisesdistally advancing the distal enclosure relative to the proximalenclosure to permit expansion of the distal portion of the valve frame.

Clause 32. The method of Clause 26-31, wherein the expanding comprisesproximally retracting the proximal enclosure relative to the distalenclosure to permit expansion of the proximal portion of the valveframe.

Clause 33. The method of Clause 26-32, wherein the expanding comprisesproximally retracting the distal enclosure relative to the proximalenclosure and distally advancing the proximal enclosure relative to thedistal enclosure to move the distal carrier assembly to a retrievalconfiguration for retracting the valve prosthesis delivery device fromthe patient.

Clause 34. The method of Clause 26-33, further comprising extending aplunger mechanism at least partially proximally out of the distalenclosure toward the proximal enclosure, aligning an outer surface ofthe distal enclosure with an outer surface of the proximal enclosure.

Clause 35. The method of Clause 26-34, wherein the proximal enclosurecomprises a proximal section having an outer diameter smaller than theproximal enclosure, and wherein when a valve anchor is loaded onto thedelivery device, the valve anchor extends between the proximal sectionand the proximal sheath in a loaded configuration.

Clause 36. The method of Clause 35, wherein the proximal section tapersin a proximal direction.

Clause 37. A method for delivering a prosthetic heart valve prosthesisto a native valve structure of a patient, the method comprising:introducing the valve prosthesis into the patient at an implantationsite via a valve prosthesis delivery device, the valve prosthesiscomprising a valve frame coupled to a valve anchor via a link mechanism,the valve prosthesis being carried by the delivery device; permittingexpansion of the valve anchor; and with the valve anchor expanded,proximally retracting the valve frame within and relative to the valveanchor to proximally slide the link mechanism along the valve anchortoward an engagement region of the valve anchor for capturing the linkmechanism in the engagement region for restricting a range of movementof the valve frame relative to the valve anchor.

Clause 38. The method of Clause 37, wherein the delivery devicecomprises a proximal sheath component and a distal carrier assembly, theproximal sheath component receiving at least a portion of the valveanchor in a proximal sheath lumen, and wherein the permitting expansionof the valve anchor comprises proximally retracting the proximal sheathin a proximal direction relative to the valve anchor to permit expansionof the valve anchor.

Clause 39. The method of Clause 38, the distal carrier assemblycomprising a distal enclosure and a proximal enclosure.

Clause 40. The method of Clause 38, further comprising distallyadvancing the valve frame into the valve anchor.

Clause 41. The method of Clause 38, further comprising expanding thedistal carrier assembly to permit expansion of the valve frame.

Clause 42. The method of Clause 38, wherein the distally advancing thevalve frame into the valve anchor comprises distally advancing the valveframe until further distal movement of the valve frame relative to thevalve anchor is restricted by the link mechanism.

Clause 43. The method of Clause 37-42, further comprising distallyadvancing the valve frame to pull the valve anchor distally relative tothe native valve structure.

Clause 44. The method of Clause 37-43, further comprising rotating thevalve frame, to rotationally adjust a position of the valve anchorrelative to the native valve structure.

Clause 45. The method of Clause 37-44, wherein the permitting expansionof the valve frame comprises proximally retracting a proximal sheath ofa delivery device to permit expansion of a base portion of the valveanchor.

Clause 46. The method of Clause 45, wherein a peak portion of the valveanchor is coupled to a grasper mechanism of a delivery device, andwherein distally urging the base portion of the valve anchor comprisesdistally advancing the grasper mechanism to convey a distal force to thevalve anchor.

Clause 47. The method of Clause 45, wherein a base portion of the valveanchor is coupled to a grasper mechanism of a delivery device, andwherein distally urging the base portion of the valve anchor comprisesdistally advancing the grasper mechanism to convey a distal force to thevalve anchor.

Clause 48. The method of Clause 38, wherein the permitting expansion ofthe valve frame comprises proximally retracting a proximal enclosure ofthe distal carrier assembly to expose a proximal portion of the valveframe.

Clause 49. The method of Clause 48, wherein the permitting expansion ofthe valve frame further comprises permitting a plunger mechanism toproximally urge a distal portion of the valve frame out of a distalenclosure of the distal carrier assembly to facilitate release of thevalve frame from the distal carrier assembly.

Clause 50. The method of Clause 49, wherein the distal carrier assemblycomprises a distal lumen and the plunger mechanism has a plunger headand biasing means disposed within the distal lumen, the plunger headbeing biased in a proximal direction by the biasing means, and whereinthe permitting expansion of the valve frame comprises permitting theplunger head to move proximally within the distal lumen and to exert aproximally oriented force on the valve frame to release the valve framefrom the distal lumen.

Clause 51. The method of Clause 49, wherein after the valve frame hasbeen released, the method further comprises distally advancing theproximal enclosure over a proximal conical portion of the plungermechanism to align an outer surface of the proximal enclosure with anouter surface of the distal enclosure of the distal carrier assembly.

Clause 52. The method of Clause 51, wherein the distally advancing theproximal enclosure over a proximal conical portion comprises abutting adistal end of the proximal enclosure against a proximal end of thedistal enclosure.

Clause Set 2: Additional Features of a Valve Prosthesis Delivery Device

Clause 1. A valve prosthesis delivery device for delivering a valveprosthesis, the valve prosthesis comprising a valve frame and a valveanchor, the delivery device comprising: an elongate core memberextending along a longitudinal axis of the system; a proximal sheathcomponent slidably coupled to the core member and comprising a proximalsheath lumen, the proximal sheath component being configured to receiveat least a portion of the valve anchor within the proximal sheath lumen,the proximal sheath being proximally retractable relative to the coremember for permitting expansion of the valve anchor; a distal carrierassembly comprising a distal enclosure and a proximal enclosure, thedistal enclosure being coupled to the core member and comprising adistal lumen, the distal enclosure being configured to receive a distalportion of the valve frame within the distal lumen in a compressedconfiguration, the proximal enclosure being coupled to the core memberproximal to the distal enclosure and comprising a proximal lumen, theproximal enclosure being configured to receive a proximal portion of thevalve frame within the proximal lumen in a compressed configuration; anda plunger mechanism and a biasing means disposed within the distal lumenof the distal carrier assembly, the plunger mechanism being moveablebetween a distal position and a proximal position within the distallumen, the plunger mechanism being biased toward the proximal positionby the biasing means for urging the valve frame out of the distal lumen.

Clause 2. The delivery device of Clause 1, wherein the plunger mechanismcomprises a plunger head that is moveable between the distal positionand the proximal position within the distal lumen, the plunger headbeing biased toward the proximal position by the biasing means.

Clause 3. The delivery device of Clause 2, wherein in the proximalposition, the plunger head extends at least partially proximally out ofthe distal lumen.

Clause 4. The delivery device of Clause 2, wherein in the proximalposition, an outer surface of the plunger head is in contact with boththe inner surface of the distal lumen and an inner surface of theproximal lumen when the proximal enclosure is distally advanced over theplunger head.

Clause 5. The delivery device of Clause 2, further comprising the valveprosthesis, wherein when the valve frame is positioned within the distallumen, the plunger head is urged to the distal position.

Clause 6. The delivery device of Clause 2, wherein the biasing meanscomprises a spring.

Clause 7. The delivery device of Clause 6, wherein the biasing meanscomprises a spring, the spring being interposed between a proximal faceof the distal enclosure and a distal face of the plunger head.

Clause 8. The delivery device of any preceding Clause wherein theplunger mechanism comprises a proximal portion that tapers in a proximaldirection.

Clause 9. The delivery device of Clause 8, wherein the plunger mechanismcomprises a plunger head with a plurality of petals extending from theplunger head, wherein the plurality of petals each form a rampedsurface.

Clause 10. The delivery device of Clause 9, wherein the plurality ofpetals are configured to deflect radially inward within the distallumen.

Clause 11. The delivery device of Clause 9, wherein the plurality ofpetals are configured to deflect radially outward when a portion of theplurality of petals exits the distal enclosure.

Clause 12. The delivery device of Clause 11, wherein in the proximalposition, the plunger mechanism extends at least partially proximallyout of the distal lumen, the proximal enclosure being distallyadvanceable over the ramped surfaces of the plurality of petals to alignan outer surface of the distal enclosure with an outer surface of theproximal enclosure for facilitating removal of the delivery device froma patient.

Clause 13. A valve prosthesis delivery device for delivering a valveprosthesis, the valve prosthesis comprising a valve frame and a valveanchor, the delivery device comprising: an elongate core memberextending along a longitudinal axis of the system; a sheath componentslidably coupled to the core member and comprising a sheath lumen, thesheath component being configured to receive at least a portion of thevalve anchor within the sheath lumen, the sheath being moveable relativeto the core member for permitting expansion of the valve anchor; aplurality of grasper components disposed within the sheath component andextending along the elongate core member, wherein a distal end of theplurality of grasper components each engage with the valve anchor forpermitting expansion of the valve anchor; and a distal hub disposed neara distal end of the elongate core member, wherein the distal hub iscoupled to the plurality of grasper components to align each of thedistal ends of the plurality of grasper components in a common plane asthe sheath component is bent.

Clause 14. The valve prosthesis delivery device of Clause 13, whereinthe distal hub is bonded to a tubular enclosure of each of the pluralityof grasper components.

Clause 15. The valve prosthesis delivery device of Clause 13 or 14,wherein the distal hub comprises a plurality of passages to permit theplurality of grasper components to pass therethrough.

Clause 16. The valve prosthesis delivery device of Clause 13-15, whereinthe distal hub comprises a core member passage to permit the elongatecore member to pass therethrough.

Clause 17. The valve prosthesis delivery device of Clause 16, whereinthe core member passage is offset from a central axis of the distal hub.

Clause 18. The valve prosthesis delivery device of Clause 13-17, whereinthe distal hub is located approximately 1 to 4 inches from the distalend of at least one of the plurality of grasper components.

Clause 19. The valve prosthesis delivery device of Clause 13-18, whereinthe distal hub is movable relative to the elongate core member.

Clause 20. The valve prosthesis delivery device of Clause 13-19, whereinthe distal hub comprises a generally cylindrical shape.

Further Considerations

In some embodiments, any of the clauses herein may depend from any oneof the independent clauses or any one of the dependent clauses. In someembodiments, any of the clauses (e.g., dependent or independent clauses)may be combined with any other one or more clauses (e.g., dependent orindependent clauses). In some embodiments, a claim may include some orall of the words (e.g., steps, operations, means or components) recitedin a clause, a sentence, a phrase or a paragraph. In some embodiments, aclaim may include some or all of the words recited in one or moreclauses, sentences, phrases or paragraphs. In some embodiments, some ofthe words in each of the clauses, sentences, phrases or paragraphs maybe removed. In some embodiments, additional words or elements may beadded to a clause, a sentence, a phrase or a paragraph. In someembodiments, the subject technology may be implemented without utilizingsome of the components, elements, functions or operations describedherein. In some embodiments, the subject technology may be implementedutilizing additional components, elements, functions or operations.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the term “distal” can denote a location or directionthat is away from a point of interest, such as a control unit or regionof the delivery system that will be used to deliver a valve prosthesisto a native valve annulus. Additionally, the term “proximal” can denotea location or direction that is closer to a point of interest, such as acontrol unit or region of the delivery system that will be used todeliver a valve prosthesis.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to mean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable (or possess every advantage that is achievable)by different embodiments of the disclosure in order to be encompassedwithin the scope of the disclosure. The use herein of “can” andderivatives thereof shall be understood in the sense of “possibly” or“optionally” as opposed to an affirmative capability.

What is claimed is:
 1. A method for delivering a prosthetic heart valveprosthesis to a native valve structure of a patient, the valveprosthesis comprising a valve frame and a valve anchor, the methodcomprising: introducing the valve prosthesis into the patient at animplantation site via a valve prosthesis delivery device, the devicecomprising a proximal sheath component and a distal carrier assembly,the proximal sheath component receiving at least a portion of the valveanchor in a proximal sheath lumen, and the distal carrier assemblycomprising a distal enclosure and a proximal enclosure, the distalenclosure being configured to receive at least a distal portion of thevalve frame; proximally retracting the proximal sheath in a proximaldirection to permit expansion of the valve anchor; and expanding thedistal carrier assembly to permit expansion of the valve frame.
 2. Themethod of claim 1, further comprising distally urging a base portion ofthe valve anchor into engagement with a native valve structure.
 3. Themethod of claim 1, further comprising proximally retracting the valveframe relative to the valve anchor to engage a link mechanismtherebetween and restricting a range of movement of the valve framerelative to the valve anchor.
 4. The method of claim 3, furthercomprising distally advancing the valve frame.
 5. The method of claim 1,wherein the expanding comprises distally advancing the distal enclosurerelative to the proximal enclosure to permit expansion of the distalportion of the valve frame.
 6. The method of claim 1, wherein theexpanding comprises proximally retracting the proximal enclosurerelative to the distal enclosure to permit expansion of a proximalportion of the valve frame.
 7. The method of claim 1, wherein theexpanding comprises proximally retracting the distal enclosure relativeto the proximal enclosure and distally advancing the proximal enclosurerelative to the distal enclosure to move the distal carrier assembly toa retrieval configuration for retracting the valve prosthesis deliverydevice from the patient.
 8. The method of claim 1, further comprisingextending a plunger mechanism at least partially proximally out of thedistal enclosure toward the proximal enclosure, aligning an outersurface of the distal enclosure with an outer surface of the proximalenclosure.
 9. The method of claim 1, wherein the proximal enclosurecomprises a proximal section having an outer diameter smaller than theproximal enclosure, and wherein when a valve anchor is loaded onto thedelivery device, the valve anchor extends between the proximal sectionand the proximal sheath in a loaded configuration.
 10. The method ofclaim 9, wherein the proximal section tapers in a proximal direction.11. A method for delivering a prosthetic heart valve prosthesis to anative valve structure of a patient, the method comprising: introducingthe valve prosthesis into the patient at an implantation site via avalve prosthesis delivery device, the valve prosthesis comprising avalve frame coupled to a valve anchor via a link mechanism, the valveprosthesis being carried by the delivery device; permitting expansion ofthe valve anchor; and with the valve anchor expanded, proximallyretracting the valve frame within and relative to the valve anchor toproximally slide the link mechanism along the valve anchor toward anengagement region of the valve anchor for capturing the link mechanismin the engagement region for restricting a range of movement of thevalve frame relative to the valve anchor.
 12. The method of claim 10,wherein the delivery device comprises a proximal sheath component and adistal carrier assembly, the proximal sheath component receiving atleast a portion of the valve anchor in a proximal sheath lumen, andwherein the permitting expansion of the valve anchor comprisesproximally retracting the proximal sheath in a proximal directionrelative to the valve anchor to permit expansion of the valve anchor.13. The method of claim 12, the distal carrier assembly comprising adistal enclosure and a proximal enclosure.
 14. The method of claim 12,further comprising distally advancing the valve frame into the valveanchor.
 15. The method of claim 12, further comprising expanding thedistal carrier assembly to permit expansion of the valve frame.
 16. Themethod of claim 12, wherein the distally advancing the valve frame intothe valve anchor comprises distally advancing the valve frame untilfurther distal movement of the valve frame relative to the valve anchoris restricted by the link mechanism.
 17. The method of claim 12, whereinthe permitting expansion of the valve frame comprises proximallyretracting a proximal enclosure of the distal carrier assembly to exposea proximal portion of the valve frame.
 18. The method of claim 17,wherein the permitting expansion of the valve frame further comprisespermitting a plunger mechanism to proximally urge a distal portion ofthe valve frame out of a distal enclosure of the distal carrier assemblyto facilitate release of the valve frame from the distal carrierassembly.
 19. The method of claim 18, wherein the distal carrierassembly comprises a distal lumen and the plunger mechanism has aplunger head and biasing means disposed within the distal lumen, theplunger head being biased in a proximal direction by the biasing means,and wherein the permitting expansion of the valve frame comprisespermitting the plunger head to move proximally within the distal lumenand to exert a proximally oriented force on the valve frame to releasethe valve frame from the distal lumen.
 20. The method of claim 18,wherein after the valve frame has been released, the method furthercomprises distally advancing the proximal enclosure over a proximalconical portion of the plunger mechanism to align an outer surface ofthe proximal enclosure with an outer surface of the distal enclosure ofthe distal carrier assembly.
 21. The method of claim 20, wherein thedistally advancing the proximal enclosure over a proximal conicalportion comprises abutting a distal end of the proximal enclosureagainst a proximal end of the distal enclosure.
 22. The method of claim11, further comprising distally advancing the valve frame to pull thevalve anchor distally relative to the native valve structure.
 23. Themethod of claim 11, further comprising rotating the valve frame, torotationally adjust a position of the valve anchor relative to thenative valve structure.
 24. The method of claim 11, wherein thepermitting expansion of the valve frame comprises proximally retractinga proximal sheath of a delivery device to permit expansion of a baseportion of the valve anchor.
 25. The method of claim 24, wherein a peakportion of the valve anchor is coupled to a grasper mechanism of adelivery device, and wherein distally urging the base portion of thevalve anchor comprises distally advancing the grasper mechanism toconvey a distal force to the valve anchor.
 26. The method of claim 24,wherein a base portion of the valve anchor is coupled to a graspermechanism of a delivery device, and wherein distally urging the baseportion of the valve anchor comprises distally advancing the graspermechanism to convey a distal force to the valve anchor.